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FDA 510(k)

BREATH-TAKER BREATH-ALERT

K-Number: K953411 · 1996-06-13

ApplicantRoxon - Universal Medical , Ltd.
Decision Date1996-06-13
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREATH-TAKER BREATH-ALERT is the device name listed in this FDA 510(k) record. The listed applicant is Roxon - Universal Medical , Ltd.. It received FDA 510(k) clearance on 1996-06-13 under 510(k) number K953411. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATH-TAKER BREATH-ALERT?

BREATH-TAKER BREATH-ALERT is a medical device that received FDA 510(k) clearance on 1996-06-13. The listed applicant is Roxon - Universal Medical , Ltd.. The 510(k) number is K953411.

When did BREATH-TAKER BREATH-ALERT receive FDA 510(k) clearance?

BREATH-TAKER BREATH-ALERT received FDA 510(k) clearance on 1996-06-13, under 510(k) number K953411.

Who is the listed applicant for BREATH-TAKER BREATH-ALERT?

The FDA 510(k) record lists Roxon - Universal Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BREATH-TAKER BREATH-ALERT?

The FDA product code for BREATH-TAKER BREATH-ALERT is BZH.

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Related Devices (Code: BZH)

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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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