SAFETYMATE TALKING FIRST AID— 510(k) K110625

Substantially Equivalent

Safetymate, Inc.

FDA 510(k) clearance K110625 for SAFETYMATE TALKING FIRST AID, Substantially Equivalent on 2011-06-17. Applicant: Safetymate, Inc.. Device class: 1.

Clearance details

Applicant
Safetymate, Inc.
Product code
Code OVR
Device class
Class 1
Regulation
21 CFR 878.4014
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Costa Mcsa, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.