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510(k) K892524

VITALOGRAPH-BREATHCO MONITOR by Vitalograph , Ltd. — Product Code CCJ

K892524 is an FDA 510(k) premarket notification submitted by Vitalograph , Ltd. for the device "VITALOGRAPH-BREATHCO MONITOR". The FDA issued a decision of Substantially Equivalent on May 5, 1989. The device falls under product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1430. Vitalograph , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1989
Date Received
April 11, 1989
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 Vitalograph , Ltd.

  • K253293 — VitaloJAK Clinic (Model 7100) (December 3, 2025)
  • K000599 — VITALOGRAPH BASE STATION (September 8, 2000)
  • K991412 — VITALOGRAPH MICRO (February 4, 2000)
  • K943678 — ELECTRONIC FLOW METER (December 14, 1995)
  • K950854 — VITALOGRAPH 2110 SOFTWARE INTERFACE (October 12, 1995)
  • K946075 — VITALOGRAPH MODEL 2120 (August 4, 1995)
  • K942779 — DISPOSABLE BACTERIOLOGICAL FILTER (July 13, 1994)
  • K925085 — ESCORT SPIROMETER (August 12, 1993)
  • K930085 — VITALOGRAPH DATA STORAGE SPIROMETER (July 26, 1993)
  • K912412 — VITALOGRAPH SPIROTRAC III (October 15, 1991)

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