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510(k) K833739

CD-102 CARBON DIOXIDE ANALYZER/RECOR by Instrumentarium Corp. — Product Code CCJ

K833739 is an FDA 510(k) premarket notification submitted by Instrumentarium Corp. for the device "CD-102 CARBON DIOXIDE ANALYZER/RECOR". The FDA issued a decision of Substantially Equivalent on December 16, 1983. The device falls under product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1430. Instrumentarium Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1983
Date Received
October 25, 1983
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 Instrumentarium Corp.

  • K022630 — MODIFICATION TO FOCUS (October 9, 2002)
  • K001729 — FOCUS (July 13, 2000)
  • K001439 — ORTHOCEPH OC100 D (June 22, 2000)
  • K992385 — ORTHOPANTOMOGRAPH OP100D (September 28, 1999)
  • K981641 — MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA (July 17, 1998)
  • K962638 — TONOCAP, TC-200 AND ACCESSORY CATHETERS (April 4, 1997)
  • K961441 — TONOMETERED SLAINE BLOOD GAS CONTROL (April 30, 1996)
  • K955018 — TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR (January 30, 1996)
  • K934478 — ALPHA STEREO (January 31, 1995)
  • K923433 — AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE (July 22, 1993)

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