The following data is part of a premarket notification filed by Brentwood Medical Technology Corp. with the FDA for Telemed 12 Lead Resting Ecg Analysis Library.
| Device ID | K010505 |
| 510k Number | K010505 |
| Device Name: | TELEMED 12 LEAD RESTING ECG ANALYSIS 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-21 |
| Decision Date | 2001-03-09 |