The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Defibrillator Analyzer Model Qed-5.
| Device ID | K904159 |
| 510k Number | K904159 |
| Device Name: | DEFIBRILLATOR ANALYZER MODEL QED-5 |
| Classification | Tester, Defibrillator |
| Applicant | BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Contact | Michael N Sevigny |
| Correspondent | Michael N Sevigny BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Product Code | DRL |
| CFR Regulation Number | 870.5325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-11 |
| Decision Date | 1991-03-18 |