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FDA 510(k)

SPIRO'AIR

K-Number: K042595 · 2005-05-04

ApplicantMorgan Scientific, Inc.
Decision Date2005-05-04
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIRO'AIR is the device name listed in this FDA 510(k) record. The listed applicant is Morgan Scientific, Inc.. It received FDA 510(k) clearance on 2005-05-04 under 510(k) number K042595. 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 SPIRO'AIR?

SPIRO'AIR is a medical device that received FDA 510(k) clearance on 2005-05-04. The listed applicant is Morgan Scientific, Inc.. The 510(k) number is K042595.

When did SPIRO'AIR receive FDA 510(k) clearance?

SPIRO'AIR received FDA 510(k) clearance on 2005-05-04, under 510(k) number K042595.

Who is the listed applicant for SPIRO'AIR?

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

What is the FDA product code for SPIRO'AIR?

The FDA product code for SPIRO'AIR is BZG.

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Other records listing Morgan Scientific, Inc. as applicant

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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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