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510(k) K831586

CM-VII PHYSIOLOGIC ANALYZER by Cybermedic, Inc. — Product Code BZM

K831586 is an FDA 510(k) premarket notification submitted by Cybermedic, Inc. for the device "CM-VII PHYSIOLOGIC ANALYZER". The FDA issued a decision of Substantially Equivalent on March 19, 1984. The device falls under product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)), a Class II device regulated under 21 CFR 868.1900. Cybermedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1984
Date Received
May 17, 1983
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 Cybermedic, Inc.

  • K941813 — VENSHIELD (May 3, 1994)
  • K914205 — PFF-1 (May 1, 1992)
  • K903959 — NEONATAL METASCOPE (November 23, 1990)
  • K884910 — MODEL 1010, CY-MET (June 12, 1989)
  • K861418 — SPINNAKER (May 9, 1986)
  • K851197 — CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH (July 8, 1985)
  • K842782 — PHYSIOLOGICAL ANALYZER CM-710 (August 17, 1984)
  • K842760 — LUNG ANALYZER CM-310 (July 26, 1984)
  • K800547 — MEDISTOR III LUNG ANALYZER (March 25, 1980)
  • K790579 — MEDISTOR II (April 4, 1979)

Other clearances for product code BZM

  • K102229 — PULMOTRACK 2020 SYSTEM (March 4, 2011)
  • 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