21 CFR 870.5325 — Tester, Defibrillator
Cardiovascular (CV) · Part 870 Subpart F—Cardiovascular Therapeutic Devices · § 870.5325
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DRL | Tester, Defibrillator | 2 | 19 | 3rd Party |
