The following data is part of a premarket notification filed by Brentwood Medical Technology Corp. with the FDA for Brentwood Real Time St And Arrhythmia Analysis Software Library.
| Device ID | K013717 |
| 510k Number | K013717 |
| Device Name: | BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY |
| Classification | Electrocardiograph |
| Applicant | BRENTWOOD MEDICAL TECHNOLOGY CORP. 3300 FUJITA ST. Torrance, CA 90505 |
| Contact | Ruomei Zhang |
| Correspondent | Ruomei Zhang BRENTWOOD MEDICAL TECHNOLOGY CORP. 3300 FUJITA ST. Torrance, CA 90505 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-08 |
| Decision Date | 2002-02-06 |
| Summary: | summary |