MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER
Device Facts
| Record ID | K954391 |
|---|---|
| Device Name | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER |
| Applicant | Bio-Tek Instruments, Inc. |
| Product Code | DRL · Cardiovascular |
| Decision Date | Nov 17, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5325 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A defibrillator tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. Some testers also provide waveform information.