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FDA 510(k)

SPIROBANK PORTABLE PC BASED SPIROMETER

K-Number: K973456 · 1998-07-22

ApplicantFuturemed America, Inc.
Decision Date1998-07-22
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROBANK PORTABLE PC BASED SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Futuremed America, Inc.. It received FDA 510(k) clearance on 1998-07-22 under 510(k) number K973456. 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 SPIROBANK PORTABLE PC BASED SPIROMETER?

SPIROBANK PORTABLE PC BASED SPIROMETER is a medical device that received FDA 510(k) clearance on 1998-07-22. The listed applicant is Futuremed America, Inc.. The 510(k) number is K973456.

When did SPIROBANK PORTABLE PC BASED SPIROMETER receive FDA 510(k) clearance?

SPIROBANK PORTABLE PC BASED SPIROMETER received FDA 510(k) clearance on 1998-07-22, under 510(k) number K973456.

Who is the listed applicant for SPIROBANK PORTABLE PC BASED SPIROMETER?

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

What is the FDA product code for SPIROBANK PORTABLE PC BASED SPIROMETER?

The FDA product code for SPIROBANK PORTABLE PC BASED SPIROMETER 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 Futuremed America, Inc. 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.

K953948SPIROVISION SV-III PC BASED SPIROMETER KIT MICROK950223DISCOVERY GRAPHIC PORTABLE SPIROMETER

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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