FDA product code DQH: Cardiograph, Apex (Vibrocardiograph)
DQH is the FDA product code for cardiograph, apex (vibrocardiograph). It is a Class II device, regulated under 21 CFR 870.2310 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under DQH. The average 510(k) review took 85 days (median 85).
Classification
| Field | Value |
|---|---|
| Device name | Cardiograph, Apex (Vibrocardiograph) |
| Device class | Class II |
| Regulation | 21 CFR 870.2310 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DQH clearance
Top DQH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bci Intl., Inc. | 1 | 1998-03-11 |
Most recent DQH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974697 | Bci Intl., Inc. | REUSABLE FINGER SENSOR 3444 | 1998-03-11 | 85 |
Recalls for DQH devices
openFDA lists no recalls for product code DQH.
Frequently asked questions
What is FDA product code DQH?
DQH is the FDA product code for cardiograph, apex (vibrocardiograph). It is a Class II device, regulated under 21 CFR 870.2310 and reviewed by the Cardiovascular panel.
What device class is DQH?
Class II, regulation 21 CFR 870.2310. Typical premarket route: 510(k).
How long does a 510(k) take for product code DQH?
Across 1 cleared submissions the average was 85 days from receipt to decision (median 85).
Which companies have the most DQH clearances?
Bci Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DQH
- Run a recall and safety report across every DQH manufacturer
- Watch product code DQH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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