OVR
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Kit, First Aid, Talking
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4014
- Medical specialty
- General, Plastic Surgery
- 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| SAFETYMATE TALKING FIRST AID (K110625) | Safetymate, Inc. | 2011-06-17 | + Add |
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Every clearance here is in the API, with alerts when new ones post.