Kit, First Aid, Talking

OVR · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.4014

Classification

FDA Product Code: OVR
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 878.4014
Review panel: HO
Medical specialty: General, Plastic Surgery
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

The device provides verbal instructions pertaining to various first aid and common medical emergencies. The device does not contain any drug or supporting device that could be applied to the patient.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 35

Source

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