PMJ — Cpr Aid Feedback Device (No Software) Class II
FDA product code PMJ covers "Cpr Aid Feedback Device (No Software)", a Class II medical device regulated under 21 CFR 870.5210. Submissions are reviewed by the Cardiovascular panel.
Classification Details
- Product Code
- PMJ
- Device Class
- Class II
- Regulation Number
- 870.5210
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR in accordance with current accepted CPR guidelines