Product code OVR

Device name

Kit, First Aid, Talking

Medical specialty

General, Plastic Surgery

Device class

1

Regulation number

878.4014

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset