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FDA 510(k)

SUREBREATH DOME, E-Z BREATHER

K-Number: K915158 · 1992-02-12

ApplicantIpax, Inc.
Decision Date1992-02-12
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUREBREATH DOME, E-Z BREATHER is the device name listed in this FDA 510(k) record. The listed applicant is Ipax, Inc.. It received FDA 510(k) clearance on 1992-02-12 under 510(k) number K915158. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUREBREATH DOME, E-Z BREATHER?

SUREBREATH DOME, E-Z BREATHER is a medical device that received FDA 510(k) clearance on 1992-02-12. The listed applicant is Ipax, Inc.. The 510(k) number is K915158.

When did SUREBREATH DOME, E-Z BREATHER receive FDA 510(k) clearance?

SUREBREATH DOME, E-Z BREATHER received FDA 510(k) clearance on 1992-02-12, under 510(k) number K915158.

Who is the listed applicant for SUREBREATH DOME, E-Z BREATHER?

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

What is the FDA product code for SUREBREATH DOME, E-Z BREATHER?

The FDA product code for SUREBREATH DOME, E-Z BREATHER is GAD.

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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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