The following data is part of a premarket notification filed by Safetymate, Inc. with the FDA for Safetymate Talking First Aid.
| Device ID | K110625 |
| 510k Number | K110625 |
| Device Name: | SAFETYMATE TALKING FIRST AID |
| Classification | Kit, First Aid, Talking |
| Applicant | SAFETYMATE, INC. 1633 MONROVIA AVE Costa Mcsa, CA 92627 |
| Contact | Sharon Cohen, Ph.d |
| Correspondent | Sharon Cohen, Ph.d SAFETYMATE, INC. 1633 MONROVIA AVE Costa Mcsa, CA 92627 |
| Product Code | OVR |
| CFR Regulation Number | 878.4014 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-04 |
| Decision Date | 2011-06-17 |
| Summary: | summary |