C-V Monitors Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “C-V Monitors Corp.” (first 1978, latest 1979), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 29 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSF | Recorder, Paper Chart | 2 | 2 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 1 | 1 |
| DRR | Amplifier And Signal Conditioner, Biopotential | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent C-V Monitors Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K792099 | 50MM WRITER MODEL CVM 9529 | DSF | 1979-10-26 | 7 |
| K790004 | MONITOR SCOPES, MODELS 9502, 9503 | DRT | 1979-02-28 | 57 |
| K781867 | WRITER, GEMINI-3 | DSF | 1979-01-05 | 63 |
| K780572 | DCG PREAMPLIFIER MODULE | DRR | 1978-05-09 | 29 |
| K780571 | BLOOD PRESSURE MODULE | DRQ | 1978-05-09 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named C-V Monitors Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under C-V Monitors Corp.?
FDA lists 5 510(k) clearances under the applicant name “C-V Monitors Corp.” (first 1978, latest 1979), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by C-V Monitors Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name C-V Monitors Corp. is 29 days.
Which FDA product codes appear under C-V Monitors Corp.?
The most frequent FDA product codes under this applicant name are DSF (Recorder, Paper Chart, 2); DRQ (Amplifier And Signal Conditioner, Transducer Signal, 1); DRR (Amplifier And Signal Conditioner, Biopotential, 1).
Next steps
- See all 5 C-V Monitors Corp. clearances with predicates and recalls
- Run predicate analysis for product code DSF, C-V Monitors Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.