Cpr Aid Feedback Device (No Software)

PMJ · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.5210

Classification

FDA Product Code: PMJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.5210
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown