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FDA 510(k)

SpiroHome Personal, SpiroHome Clinic

K-Number: K213754 · 2023-06-12

ApplicantInofab Saglik Teknolojileri A.S
Decision Date2023-06-12
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SpiroHome Personal, SpiroHome Clinic is the device name listed in this FDA 510(k) record. The listed applicant is Inofab Saglik Teknolojileri A.S. It received FDA 510(k) clearance on 2023-06-12 under 510(k) number K213754. 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 SpiroHome Personal, SpiroHome Clinic?

SpiroHome Personal, SpiroHome Clinic is a medical device that received FDA 510(k) clearance on 2023-06-12. The listed applicant is Inofab Saglik Teknolojileri A.S. The 510(k) number is K213754.

When did SpiroHome Personal, SpiroHome Clinic receive FDA 510(k) clearance?

SpiroHome Personal, SpiroHome Clinic received FDA 510(k) clearance on 2023-06-12, under 510(k) number K213754.

Who is the listed applicant for SpiroHome Personal, SpiroHome Clinic?

The FDA 510(k) record lists Inofab Saglik Teknolojileri A.S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpiroHome Personal, SpiroHome Clinic?

The FDA product code for SpiroHome Personal, SpiroHome Clinic is BZG.

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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