Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FUKUDA SANGYO MODEL SPIROANALYZER ST-180

K-Number: K943546 · 1995-02-23

ApplicantSpirosoft Northamerica, Inc.
Decision Date1995-02-23
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FUKUDA SANGYO MODEL SPIROANALYZER ST-180 is the device name listed in this FDA 510(k) record. The listed applicant is Spirosoft Northamerica, Inc.. It received FDA 510(k) clearance on 1995-02-23 under 510(k) number K943546. 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 FUKUDA SANGYO MODEL SPIROANALYZER ST-180?

FUKUDA SANGYO MODEL SPIROANALYZER ST-180 is a medical device that received FDA 510(k) clearance on 1995-02-23. The listed applicant is Spirosoft Northamerica, Inc.. The 510(k) number is K943546.

When did FUKUDA SANGYO MODEL SPIROANALYZER ST-180 receive FDA 510(k) clearance?

FUKUDA SANGYO MODEL SPIROANALYZER ST-180 received FDA 510(k) clearance on 1995-02-23, under 510(k) number K943546.

Who is the listed applicant for FUKUDA SANGYO MODEL SPIROANALYZER ST-180?

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

What is the FDA product code for FUKUDA SANGYO MODEL SPIROANALYZER ST-180?

The FDA product code for FUKUDA SANGYO MODEL SPIROANALYZER ST-180 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

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑