510(k) K110625
K110625 is an FDA 510(k) premarket notification submitted by Safetymate, Inc. for the device "SAFETYMATE TALKING FIRST AID". The FDA issued a decision of Substantially Equivalent on June 17, 2011. The device falls under product code OVR (Kit, First Aid, Talking), a Class I device regulated under 21 CFR 878.4014.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2011
- Date Received
- March 4, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, First Aid, Talking
- Device Class
- Class I
- Regulation Number
- 878.4014
- Review Panel
- HO
- Submission Type
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.