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FDA 510(k)

EASY ON-PC SPIROMETER

K-Number: K090034 · 2009-06-02

ApplicantNdd Medizitechnik AG
Decision Date2009-06-02
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EASY ON-PC SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Ndd Medizitechnik AG. It received FDA 510(k) clearance on 2009-06-02 under 510(k) number K090034. 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 EASY ON-PC SPIROMETER?

EASY ON-PC SPIROMETER is a medical device that received FDA 510(k) clearance on 2009-06-02. The listed applicant is Ndd Medizitechnik AG. The 510(k) number is K090034.

When did EASY ON-PC SPIROMETER receive FDA 510(k) clearance?

EASY ON-PC SPIROMETER received FDA 510(k) clearance on 2009-06-02, under 510(k) number K090034.

Who is the listed applicant for EASY ON-PC SPIROMETER?

The FDA 510(k) record lists Ndd Medizitechnik AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASY ON-PC SPIROMETER?

The FDA product code for EASY ON-PC SPIROMETER is BZG.

Related Clinical Trials

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Other records listing Ndd Medizitechnik AG 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.

K120635EASYONE PRO RESPIRATORY TESTING DEVICEK091428EASYONE PRO RESPIRATORY ANALYSIS SYSTEM

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

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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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