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510(k) K980878

PULMOTRACK,MODEL 1010 by Karmel Medical Acoustic Technologies , Ltd. — Product Code BZM

K980878 is an FDA 510(k) premarket notification submitted by Karmel Medical Acoustic Technologies , Ltd. for the device "PULMOTRACK,MODEL 1010". The FDA issued a decision of Substantially Equivalent on December 28, 1998. 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
December 28, 1998
Date Received
March 9, 1998
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

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  • K071955 — WIM-PC, MODEL 1010 (November 1, 2007)
  • K012387 — STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM (April 23, 2002)
  • 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)
  • K880550 — BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS (July 25, 1988)

FDA data resources