510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PMJClass II

Cpr Aid Feedback Device (No Software)

21 CFR 870.5210 / Cardiovascular
FDA source (opens on fda.gov)

PMJ is the FDA product code for Cpr Aid Feedback Device (No Software), a class II device type, regulated under 21 CFR 870.5210. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PMJ
Device name
Cpr Aid Feedback Device (No Software)
FDA 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
Regulation
21 CFR 870.5210
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code