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FDA 510(k)

ANASCIENT BREATH MONITOR

K-Number: K110810 · 2011-06-21

ApplicantInvoy Technologies, LLC
Decision Date2011-06-21
Product CodeBZL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ANASCIENT BREATH MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Invoy Technologies, LLC. It received FDA 510(k) clearance on 2011-06-21 under 510(k) number K110810. The device is classified under product code BZL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANASCIENT BREATH MONITOR?

ANASCIENT BREATH MONITOR is a medical device that received FDA 510(k) clearance on 2011-06-21. The listed applicant is Invoy Technologies, LLC. The 510(k) number is K110810.

When did ANASCIENT BREATH MONITOR receive FDA 510(k) clearance?

ANASCIENT BREATH MONITOR received FDA 510(k) clearance on 2011-06-21, under 510(k) number K110810.

Who is the listed applicant for ANASCIENT BREATH MONITOR?

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

What is the FDA product code for ANASCIENT BREATH MONITOR?

The FDA product code for ANASCIENT BREATH MONITOR is BZL.

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Related Devices (Code: BZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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