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FDA 510(k)

Vitalograph Model 6300 micro

K-Number: K160253 · 2016-08-26

ApplicantVitalograph (Ireland) , Ltd.
Decision Date2016-08-26
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Vitalograph Model 6300 micro 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 2016-08-26 under 510(k) number K160253. 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 Vitalograph Model 6300 micro?

Vitalograph Model 6300 micro is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Vitalograph (Ireland) , Ltd.. The 510(k) number is K160253.

When did Vitalograph Model 6300 micro receive FDA 510(k) clearance?

Vitalograph Model 6300 micro received FDA 510(k) clearance on 2016-08-26, under 510(k) number K160253.

Who is the listed applicant for Vitalograph Model 6300 micro?

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 Vitalograph Model 6300 micro?

The FDA product code for Vitalograph Model 6300 micro 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 AlphaK201562SpirotracK200550Vitalograph Model 2120 In2itive eDiary

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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