The following data is part of a premarket notification filed by Andries Tek, Inc. with the FDA for Andries Physical Assessment Computer.
| Device ID | K870545 |
| 510k Number | K870545 |
| Device Name: | ANDRIES PHYSICAL ASSESSMENT COMPUTER |
| Classification | Phonocardiograph |
| Applicant | ANDRIES TEK, INC. 8868 RESEARCH BLVD. BLDG. 202 Austin, TX 78758 |
| Contact | Francis Andries |
| Correspondent | Francis Andries ANDRIES TEK, INC. 8868 RESEARCH BLVD. BLDG. 202 Austin, TX 78758 |
| Product Code | DQC |
| CFR Regulation Number | 870.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-10 |
| Decision Date | 1987-08-14 |