SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY— 510(k) K874902

Name: FDA 510(k) clearance K874902
Creator: U.S. Food and Drug Administration
Published: 1988-06-07

Substantially Equivalent

Gomi Medical Instruments

FDA 510(k) clearance K874902 for SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY, Substantially Equivalent on 1988-06-07. Applicant: Gomi Medical Instruments. Device class: 2.

Clearance details

Applicant: Gomi Medical Instruments
Product code: Code BZM
Device class: Class 2
Regulation: 21 CFR 868.1900
Advisory panel: Anesthesiology
Date received: 1987-12-01
Decision date: 1988-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Anselmo, CA, US

Download summary PDF View on FDA.gov ↗

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