The following data is part of a premarket notification filed by Brentwood Medical Products, Inc. with the FDA for Brentwood Pc-ecg.
| Device ID | K955023 |
| 510k Number | K955023 |
| Device Name: | BRENTWOOD PC-ECG |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | BRENTWOOD MEDICAL PRODUCTS, INC. 3555 LOMITA BLVD. STE.E Torrance, CA 90505 |
| Contact | Chandu Patil |
| Correspondent | Chandu Patil BRENTWOOD MEDICAL PRODUCTS, INC. 3555 LOMITA BLVD. STE.E Torrance, CA 90505 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-02 |
| Decision Date | 1997-01-22 |