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510(k) K900322

CO/CMD-1 by Spirometrics, Inc. — Product Code CCJ

K900322 is an FDA 510(k) premarket notification submitted by Spirometrics, Inc. for the device "CO/CMD-1". The FDA issued a decision of Substantially Equivalent on April 30, 1990. The device falls under product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1430. Spirometrics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1990
Date Received
January 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1430
Review Panel
AN
Submission Type

Other clearances by Spirometrics, Inc.

  • K915059 — PEAK FLOW MONITOR (July 27, 1992)
  • K911358 — CMD/DLCO DIAGNOSTIC SPIROMETER (July 22, 1991)
  • K901057 — SPIROMETRICS MODEL 2600 MIRO SPIROMETER (April 3, 1990)
  • K900673 — SERIAL FLOW (April 3, 1990)
  • K884464 — SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR (January 19, 1989)
  • K884465 — SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM) (November 9, 1988)
  • K863953 — SPIROMETRICS MODEL 2500 FLOWMATE(TM) (January 15, 1987)
  • K850045 — SPIROMETRICS 2453 & SMI III (February 14, 1985)
  • K844333 — SPIROMETRICS 2451 & SMI I (November 20, 1984)
  • K831497 — SPIROMETRICS BREON 2400 & SMI 2400 (June 24, 1983)

Other clearances for product code CCJ

  • K253119 — CoSense ETCO Monitor (May 29, 2026)
  • K211918 — iCOquit® Smokerlyzer® (December 21, 2021)
  • K201206 — Pivot Breath Sensor (June 30, 2021)
  • K173238 — ToxCO (April 4, 2019)
  • K171129 — CO Check Pro, CO Screen (March 2, 2018)
  • K171408 — Carbon Monoxide Breath Sensor System (COBSS) (September 29, 2017)
  • K151107 — CoSense ETCO Monitor (July 22, 2015)
  • K130036 — COSENSE CO MONITOR (January 14, 2014)
  • K121768 — COSENSE (October 31, 2012)
  • K082315 — EC50 MICRO+ SMOKERLYZER (February 1, 2010)

FDA data resources