The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for External Pacemaker Analyzer Model Pma-1.
| Device ID | K903966 |
| 510k Number | K903966 |
| Device Name: | EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Contact | Michael Sevigny |
| Correspondent | Michael Sevigny BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-28 |
| Decision Date | 1991-06-19 |