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FDA 510(k)

SUREBREATH DOME

K-Number: K884076 · 1988-10-07

ApplicantIpax, Inc.
Decision Date1988-10-07
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUREBREATH DOME is the device name listed in this FDA 510(k) record. The listed applicant is Ipax, Inc.. It received FDA 510(k) clearance on 1988-10-07 under 510(k) number K884076. 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?

SUREBREATH DOME is a medical device that received FDA 510(k) clearance on 1988-10-07. The listed applicant is Ipax, Inc.. The 510(k) number is K884076.

When did SUREBREATH DOME receive FDA 510(k) clearance?

SUREBREATH DOME received FDA 510(k) clearance on 1988-10-07, under 510(k) number K884076.

Who is the listed applicant for SUREBREATH DOME?

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?

The FDA product code for SUREBREATH DOME is GAD.

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Other records listing Ipax, Inc. as applicant

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Related Devices (Code: 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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