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FDA 510(k)

MICRODL DIARYCARD SPIROMETER

K-Number: K965042 · 1997-06-17

ApplicantMicro Direct, Inc.
Decision Date1997-06-17
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MICRODL DIARYCARD SPIROMETER 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 1997-06-17 under 510(k) number K965042. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRODL DIARYCARD SPIROMETER?

MICRODL DIARYCARD SPIROMETER is a medical device that received FDA 510(k) clearance on 1997-06-17. The listed applicant is Micro Direct, Inc.. The 510(k) number is K965042.

When did MICRODL DIARYCARD SPIROMETER receive FDA 510(k) clearance?

MICRODL DIARYCARD SPIROMETER received FDA 510(k) clearance on 1997-06-17, under 510(k) number K965042.

Who is the listed applicant for MICRODL DIARYCARD SPIROMETER?

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 MICRODL DIARYCARD SPIROMETER?

The FDA product code for MICRODL DIARYCARD SPIROMETER is BZG.

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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.

K033688MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITYK031102MICROLAB SPIROMETERK030586MICROPEAKK973314SPIROSAFE FILTERK963376MICRO H2K963035MICRO SPIROMETER

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Related Devices (Code: BZG)

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.

K251777MESI mTABLET SPIROMesi D.O.O.K241843TD-7301 Spirometer (TD-7301)Gostar Co., Ltd.K231416Air Next (NVD-02)Nuvoair ABK230501Spirobank OxiMir Medical International Research USAK230178EasyOne Sky SpirometerNdd Medizintechnik AGK222525Alveoair Digital SpirometerRoundworks Technologies Private Limited

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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