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FDA 510(k)

SPIROMATE AS-600

K-Number: K862023 · 1986-06-17

ApplicantRiko Medical & Scientific Instrument Corp.
Decision Date1986-06-17
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROMATE AS-600 is the device name listed in this FDA 510(k) record. The listed applicant is Riko Medical & Scientific Instrument Corp.. It received FDA 510(k) clearance on 1986-06-17 under 510(k) number K862023. 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 SPIROMATE AS-600?

SPIROMATE AS-600 is a medical device that received FDA 510(k) clearance on 1986-06-17. The listed applicant is Riko Medical & Scientific Instrument Corp.. The 510(k) number is K862023.

When did SPIROMATE AS-600 receive FDA 510(k) clearance?

SPIROMATE AS-600 received FDA 510(k) clearance on 1986-06-17, under 510(k) number K862023.

Who is the listed applicant for SPIROMATE AS-600?

The FDA 510(k) record lists Riko Medical & Scientific Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIROMATE AS-600?

The FDA product code for SPIROMATE AS-600 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 Riko Medical & Scientific Instrument Corp. 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.

K853922PLOTTER FOR AS-500K842372SPIROMATE AS-500

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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