FDA product code DQC: Phonocardiograph
DQC is the FDA product code for phonocardiograph. It is a Class I device, regulated under 21 CFR 870.2390 and reviewed by the Cardiovascular panel. FDA has cleared 18 510(k) submissions under DQC, from 14 different applicants. The average 510(k) review took 144 days (median 134).
Classification
| Field | Value |
|---|---|
| Device name | Phonocardiograph |
| Device class | Class I |
| Regulation | 21 CFR 870.2390 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DQC clearance
Top DQC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intl. Acoustics, Inc. | 3 | 1987-12-07 |
| Life Sciences Manufacturing, Inc. | 2 | 1990-07-18 |
| Honeywell, Inc. | 2 | 1981-07-01 |
| Cardiophonics, Inc. | 1 | 1996-03-01 |
| Flowscan, Inc. | 1 | 1995-09-19 |
9 more applicants have DQC clearances. See the full list in Caduvo.
Most recent DQC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950537 | Cardiophonics, Inc. | CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH | 1996-03-01 | 388 |
| K952651 | Flowscan, Inc. | LIFE SOUND SENSOR | 1995-09-19 | 102 |
| K943726 | Technology Applications Assoc., Inc. | ACOUSTIC RECORDER | 1994-11-30 | 120 |
| K924054 | Echo Ultrasound | PHONOCARDIOGRAPH | 1993-01-22 | 163 |
| K902185 | Reeves Scientific, Inc. | DYNAMIC SPECTRAL PHONOCARDIOGRAPH | 1991-03-25 | 315 |
Recalls for DQC devices
openFDA lists no recalls for product code DQC.
Frequently asked questions
What is FDA product code DQC?
DQC is the FDA product code for phonocardiograph. It is a Class I device, regulated under 21 CFR 870.2390 and reviewed by the Cardiovascular panel.
What device class is DQC?
Class I, regulation 21 CFR 870.2390. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DQC?
Across 18 cleared submissions the average was 144 days from receipt to decision (median 134).
Which companies have the most DQC clearances?
Intl. Acoustics, Inc. (3); Life Sciences Manufacturing, Inc. (2); Honeywell, Inc. (2); Cardiophonics, Inc. (1); Flowscan, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DQC
- Run a recall and safety report across every DQC manufacturer
- Watch product code DQC 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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