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510(k) K874902

SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY by Gomi Medical Instruments — Product Code BZM

K874902 is an FDA 510(k) premarket notification submitted by Gomi Medical Instruments for the device "SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY". The FDA issued a decision of Substantially Equivalent on June 7, 1988. The device falls under product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)), a Class II device regulated under 21 CFR 868.1900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1988
Date Received
December 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Interpretor (Diagnostic)
Device Class
Class II
Regulation Number
868.1900
Review Panel
AN
Submission Type

Other clearances for product code BZM

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  • K090863 — PERSONAL WHEEZOMETER (September 21, 2009)
  • K071955 — WIM-PC, MODEL 1010 (November 1, 2007)
  • K012387 — STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM (April 23, 2002)
  • K980878 — PULMOTRACK,MODEL 1010 (December 28, 1998)
  • K974200 — ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM (July 21, 1998)
  • K955432 — CPX, CCM, CATH WITH 15% CO2 (July 1, 1996)
  • K923209 — MEDGRAPHICS EXERCISE CONSULT (March 11, 1993)
  • K911143 — PB100 DIAGNOSTIC SPIROMETER (November 29, 1991)
  • K896345 — EXERCISE EVALUATION SYSTEM 2010 (January 20, 1990)

FDA data resources