OVR — Kit, First Aid, Talking Class I
FDA product code OVR covers "Kit, First Aid, Talking", a Class I medical device regulated under 21 CFR 878.4014. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OVR
- Device Class
- Class I
- Regulation Number
- 878.4014
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K110625 | safetymate | SAFETYMATE TALKING FIRST AID | June 17, 2011 |