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FDA 510(k)

RESPIROMETER

K-Number: K832401 · 1984-04-30

ApplicantKinetix
Decision Date1984-04-30
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Kinetix. It received FDA 510(k) clearance on 1984-04-30 under 510(k) number K832401. 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 RESPIROMETER?

RESPIROMETER is a medical device that received FDA 510(k) clearance on 1984-04-30. The listed applicant is Kinetix. The 510(k) number is K832401.

When did RESPIROMETER receive FDA 510(k) clearance?

RESPIROMETER received FDA 510(k) clearance on 1984-04-30, under 510(k) number K832401.

Who is the listed applicant for RESPIROMETER?

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

What is the FDA product code for RESPIROMETER?

The FDA product code for RESPIROMETER is BZG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kinetix 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.

K840459IMPROVED MOUTHPIECEK833420KINETIX MOUTHPIECEK833012INSPIROMETER

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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