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FDA 510(k)

FLOWMATE LTE

K-Number: K954759 · 1996-04-12

ApplicantSpirometrics Medical Equipment Co.
Decision Date1996-04-12
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLOWMATE LTE is the device name listed in this FDA 510(k) record. The listed applicant is Spirometrics Medical Equipment Co.. It received FDA 510(k) clearance on 1996-04-12 under 510(k) number K954759. 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 FLOWMATE LTE?

FLOWMATE LTE is a medical device that received FDA 510(k) clearance on 1996-04-12. The listed applicant is Spirometrics Medical Equipment Co.. The 510(k) number is K954759.

When did FLOWMATE LTE receive FDA 510(k) clearance?

FLOWMATE LTE received FDA 510(k) clearance on 1996-04-12, under 510(k) number K954759.

Who is the listed applicant for FLOWMATE LTE?

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

What is the FDA product code for FLOWMATE LTE?

The FDA product code for FLOWMATE LTE 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 Spirometrics Medical Equipment Co. 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.

K001528PC FLOW +K982956FLOWMATE II PLUS, MODEL #4000

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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