510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OVRClass I

Kit, First Aid, Talking

21 CFR 878.4014 / General, Plastic Surgery
FDA source (opens on fda.gov)

OVR is the FDA product code for Kit, First Aid, Talking, a class I device type, regulated under 21 CFR 878.4014. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OVR
Device name
Kit, First Aid, Talking
FDA 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.
Regulation
21 CFR 878.4014
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OVR

By decision year
1 clearance under product code OVR with a decision year between 2011 and 2011, 2011 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OVR by decision year
YearClearances
20111

Applicants with the most clearances

Product code OVR
Applicants holding the most 510(k) clearances under product code OVR
ApplicantClearances
Safetymate, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order