The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Models Qed-6, 6m And 6h Defibrillator Analyzer With Optional Universal Pacemaker Load Adapter.
| Device ID | K954391 |
| 510k Number | K954391 |
| Device Name: | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER |
| Classification | Tester, Defibrillator |
| Applicant | BIO-TEK INSTRUMENTS, INC. HIGHLAND PARK P.O. BOX 998 Winooski, VT 05404 -0998 |
| Contact | Michael N Sevigny |
| Correspondent | Michael N Sevigny BIO-TEK INSTRUMENTS, INC. HIGHLAND PARK P.O. BOX 998 Winooski, VT 05404 -0998 |
| Product Code | DRL |
| CFR Regulation Number | 870.5325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-19 |
| Decision Date | 1995-11-17 |
| Summary: | summary |