The following data is part of a premarket notification filed by Prucka Engineering, Inc. with the FDA for Cardiolab Amplifier Module (cam).
| Device ID | K910307 |
| 510k Number | K910307 |
| Device Name: | CARDIOLAB AMPLIFIER MODULE (CAM) |
| Classification | Amplifier And Signal Conditioner, Biopotential |
| Applicant | PRUCKA ENGINEERING, INC. 8030 EL RIO Houston, TX 77054 |
| Contact | Matthew W Prucka |
| Correspondent | Matthew W Prucka PRUCKA ENGINEERING, INC. 8030 EL RIO Houston, TX 77054 |
| Product Code | DRR |
| CFR Regulation Number | 870.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-24 |
| Decision Date | 1991-04-12 |