21 CFR 870.3700 — Programmer, Pacemaker
Cardiovascular (CV) · Part 870 Subpart D—Cardiovascular Prosthetic Devices · § 870.3700
Identification
A pacemaker programmer is a device used to noninvasively change one or more of the electrical operating characteristics of a pacemaker.
Classification Rationale
Class III (premarket approval).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KRG | Programmer, Pacemaker | 3 | 25 |
