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FDA 510(k)

RESCUE BREATHER

K-Number: K955520 · 1996-10-08

ApplicantInternational Safety, Inc.
Decision Date1996-10-08
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESCUE BREATHER is the device name listed in this FDA 510(k) record. The listed applicant is International Safety, Inc.. It received FDA 510(k) clearance on 1996-10-08 under 510(k) number K955520. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESCUE BREATHER?

RESCUE BREATHER is a medical device that received FDA 510(k) clearance on 1996-10-08. The listed applicant is International Safety, Inc.. The 510(k) number is K955520.

When did RESCUE BREATHER receive FDA 510(k) clearance?

RESCUE BREATHER received FDA 510(k) clearance on 1996-10-08, under 510(k) number K955520.

Who is the listed applicant for RESCUE BREATHER?

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

What is the FDA product code for RESCUE BREATHER?

The FDA product code for RESCUE BREATHER is CBP.

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Official Source

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

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