SAFETYMATE TALKING FIRST AID
FDA 510(k) clearance K110625 · decided 2011-06-17
Clearance details
- K-number
- K110625
- Device name
- SAFETYMATE TALKING FIRST AID
- Applicant
- Safetymate, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-04
- Decision date
- 2011-06-17
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- OVR
- Device class
- 1
- Regulation number
- 878.4014
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Costa Mcsa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.