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510(k) K872024

CO2/02 MONITOR MULTINEX by Datascope Corp. — Product Code CCI

K872024 is an FDA 510(k) premarket notification submitted by Datascope Corp. for the device "CO2/02 MONITOR MULTINEX". The FDA issued a decision of Substantially Equivalent on March 31, 1988. The device falls under product code CCI (Analyzer, Gas, Nitrogen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1690. Datascope Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1988
Date Received
May 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Nitrogen, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1690
Review Panel
AN
Submission Type

Other clearances by Datascope Corp.

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  • K172305 — CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (October 12, 2017)
  • K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Batter (January 31, 2017)
  • K151254 — CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (July 2, 2015)
  • K133074 — MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND A (December 12, 2013)
  • K071805 — NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX (September 25, 2007)
  • K062569 — SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING (February 14, 2007)
  • K062098 — SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX (February 5, 2007)
  • K063525 — DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 IN (January 5, 2007)

Other clearances for product code CCI

  • K771516 — CAPILLARY SAMPLE LINE (August 16, 1977)

FDA data resources