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FDA 510(k)

Safey Pocket Spirometer

K-Number: K201002 · 2020-07-30

ApplicantSafey Medical Devices Pvt, Ltd.
Decision Date2020-07-30
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Safey Pocket Spirometer is the device name listed in this FDA 510(k) record. The listed applicant is Safey Medical Devices Pvt, Ltd.. It received FDA 510(k) clearance on 2020-07-30 under 510(k) number K201002. 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 Safey Pocket Spirometer?

Safey Pocket Spirometer is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is Safey Medical Devices Pvt, Ltd.. The 510(k) number is K201002.

When did Safey Pocket Spirometer receive FDA 510(k) clearance?

Safey Pocket Spirometer received FDA 510(k) clearance on 2020-07-30, under 510(k) number K201002.

Who is the listed applicant for Safey Pocket Spirometer?

The FDA 510(k) record lists Safey Medical Devices Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safey Pocket Spirometer?

The FDA product code for Safey Pocket Spirometer is BZG.

Other records listing Safey Medical Devices Pvt, Ltd. 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.

K200832Safey Peak Flow Meter

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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