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FDA 510(k)

SPIROTECH ST-5500

K-Number: K823770 · 1983-06-03

ApplicantSpirotech, Inc.
Decision Date1983-06-03
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROTECH ST-5500 is the device name listed in this FDA 510(k) record. The listed applicant is Spirotech, Inc.. It received FDA 510(k) clearance on 1983-06-03 under 510(k) number K823770. 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 SPIROTECH ST-5500?

SPIROTECH ST-5500 is a medical device that received FDA 510(k) clearance on 1983-06-03. The listed applicant is Spirotech, Inc.. The 510(k) number is K823770.

When did SPIROTECH ST-5500 receive FDA 510(k) clearance?

SPIROTECH ST-5500 received FDA 510(k) clearance on 1983-06-03, under 510(k) number K823770.

Who is the listed applicant for SPIROTECH ST-5500?

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

What is the FDA product code for SPIROTECH ST-5500?

The FDA product code for SPIROTECH ST-5500 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 Spirotech, 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.

K840972SPIROTECH ST-550K823771SPIROTECH 300

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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