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FDA 510(k)

Spirotrac

K-Number: K201562 · 2020-10-14

ApplicantVitalograph Ireland, Ltd.
Decision Date2020-10-14
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Spirotrac is the device name listed in this FDA 510(k) record. The listed applicant is Vitalograph Ireland, Ltd.. It received FDA 510(k) clearance on 2020-10-14 under 510(k) number K201562. 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 Spirotrac?

Spirotrac is a medical device that received FDA 510(k) clearance on 2020-10-14. The listed applicant is Vitalograph Ireland, Ltd.. The 510(k) number is K201562.

When did Spirotrac receive FDA 510(k) clearance?

Spirotrac received FDA 510(k) clearance on 2020-10-14, under 510(k) number K201562.

Who is the listed applicant for Spirotrac?

The FDA 510(k) record lists Vitalograph Ireland, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spirotrac?

The FDA product code for Spirotrac is BZG.

Other records listing Vitalograph Ireland, 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.

K223818Model 9160 VitaloQUBK221030Model 9100 PFT/DICOK212938Vitalograph Model 6000 AlphaK200550Vitalograph Model 2120 In2itive eDiaryK160253Vitalograph Model 6300 micro

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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