KRF · Charger, Pacemaker
Cardiovascular · 21 CFR 870.3670 · Class 1
Overview
| Product Code | KRF |
|---|---|
| Device Name | Charger, Pacemaker |
| Regulation | 21 CFR 870.3670 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
Identification
A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable pacemaker.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
