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)

SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.

K-Number: K904117 · 1991-02-25

ApplicantDawn Medical
Decision Date1991-02-25
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST. is the device name listed in this FDA 510(k) record. The listed applicant is Dawn Medical. It received FDA 510(k) clearance on 1991-02-25 under 510(k) number K904117. 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 SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.?

SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST. is a medical device that received FDA 510(k) clearance on 1991-02-25. The listed applicant is Dawn Medical. The 510(k) number is K904117.

When did SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST. receive FDA 510(k) clearance?

SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST. received FDA 510(k) clearance on 1991-02-25, under 510(k) number K904117.

Who is the listed applicant for SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.?

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

What is the FDA product code for SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.?

The FDA product code for SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST. 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 Dawn Medical 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.

K933135DAWN DISPOSABLE BIOPSY FORCEPSK904118SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST.K905733SEROMA-CATH CLOSE DRAINAGE SYSTEM

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.

↑