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FDA 510(k)

SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST.

K-Number: K904118 · 1991-02-25

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

Device Summary

SOMNIPROBE II NASAL AND BUCCAL AIRFLOW 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 K904118. 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 SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST.?

SOMNIPROBE II NASAL AND BUCCAL AIRFLOW 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 K904118.

When did SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST. receive FDA 510(k) clearance?

SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST. received FDA 510(k) clearance on 1991-02-25, under 510(k) number K904118.

Who is the listed applicant for SOMNIPROBE II NASAL AND BUCCAL AIRFLOW 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 SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST.?

The FDA product code for SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST. is BZG.

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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 FORCEPSK904117SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION 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

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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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