MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER— 510(k) K954391
Substantially EquivalentBio-Tek Instruments, Inc.
FDA 510(k) clearance K954391 for MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER, Substantially Equivalent on 1995-11-17. Applicant: Bio-Tek Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Tek Instruments, Inc.
- Product code
- Code DRL
- Device class
- Class 2
- Regulation
- 21 CFR 870.5325
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Winooski, VT, US
Recent devices under product code DRL
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