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510(k) K090863

PERSONAL WHEEZOMETER by Karmelsonix — Product Code BZM

K090863 is an FDA 510(k) premarket notification submitted by Karmelsonix for the device "PERSONAL WHEEZOMETER". The FDA issued a decision of Substantially Equivalent on September 21, 2009. The device falls under product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)), a Class II device regulated under 21 CFR 868.1900. Karmelsonix has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2009
Date Received
March 30, 2009
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 by Karmelsonix

  • K102229 — PULMOTRACK 2020 SYSTEM (March 4, 2011)
  • K101022 — PULMOTRACK 5050 WHOLTER, MODEL 5050 (July 9, 2010)
  • K071955 — WIM-PC, MODEL 1010 (November 1, 2007)

Other clearances for product code BZM

  • K102229 — PULMOTRACK 2020 SYSTEM (March 4, 2011)
  • 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)
  • K880550 — BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS (July 25, 1988)

FDA data resources