The following data is part of a premarket notification filed by Technology Applications Assoc., Inc. with the FDA for Acoustic Recorder.
| Device ID | K943726 |
| 510k Number | K943726 |
| Device Name: | ACOUSTIC RECORDER |
| Classification | Phonocardiograph |
| Applicant | TECHNOLOGY APPLICATIONS ASSOC., INC. 2905 COWLEY WAY, SUITE E SAN DIEGO, CA 92117 |
| Contact | DAVID V SIRIANO |
| Correspondent | DAVID V SIRIANO TECHNOLOGY APPLICATIONS ASSOC., INC. 2905 COWLEY WAY, SUITE E SAN DIEGO, CA 92117 |
| Product Code | DQC |
| CFR Regulation Number | 870.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-02 |
| Decision Date | 1994-11-30 |