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FDA 510(k)

MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY

K-Number: K033688 · 2004-05-19

ApplicantMicro Direct, Inc.
Decision Date2004-05-19
Product CodeNRH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY is the device name listed in this FDA 510(k) record. The listed applicant is Micro Direct, Inc.. It received FDA 510(k) clearance on 2004-05-19 under 510(k) number K033688. The device is classified under product code NRH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY?

MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY is a medical device that received FDA 510(k) clearance on 2004-05-19. The listed applicant is Micro Direct, Inc.. The 510(k) number is K033688.

When did MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY receive FDA 510(k) clearance?

MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY received FDA 510(k) clearance on 2004-05-19, under 510(k) number K033688.

Who is the listed applicant for MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY?

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

What is the FDA product code for MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY?

The FDA product code for MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY is NRH.

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Other records listing Micro Direct, Inc. as applicant

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.

K031102MICROLAB SPIROMETERK030586MICROPEAKK973314SPIROSAFE FILTERK965042MICRODL DIARYCARD SPIROMETERK963376MICRO H2K963035MICRO SPIROMETER

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Related Devices (Code: NRH)

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.

K963376MICRO H2Micro Direct, Inc.K882499JAYCO HYDROGEN MONITOREnteron, Inc.K874892VITALOGRAPH-EC60 HYDROGEN MONITORVitalograph , Ltd.

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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