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FDA 510(k)

SAFETYMATE TALKING FIRST AID

K-Number: K110625 · 2011-06-17

ApplicantSafetymate, Inc.
Decision Date2011-06-17
Product CodeOVR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SAFETYMATE TALKING FIRST AID is the device name listed in this FDA 510(k) record. The listed applicant is Safetymate, Inc.. It received FDA 510(k) clearance on 2011-06-17 under 510(k) number K110625. The device is classified under product code OVR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFETYMATE TALKING FIRST AID?

SAFETYMATE TALKING FIRST AID is a medical device that received FDA 510(k) clearance on 2011-06-17. The listed applicant is Safetymate, Inc.. The 510(k) number is K110625.

When did SAFETYMATE TALKING FIRST AID receive FDA 510(k) clearance?

SAFETYMATE TALKING FIRST AID received FDA 510(k) clearance on 2011-06-17, under 510(k) number K110625.

Who is the listed applicant for SAFETYMATE TALKING FIRST AID?

The FDA 510(k) record lists Safetymate, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFETYMATE TALKING FIRST AID?

The FDA product code for SAFETYMATE TALKING FIRST AID is OVR.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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