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510(k) K926451

DATASCOPE MULTINEX II by Datascope Corp. — Product Code CBQ

K926451 is an FDA 510(k) premarket notification submitted by Datascope Corp. for the device "DATASCOPE MULTINEX II". The FDA issued a decision of Substantially Equivalent on August 25, 1993. The device falls under product code CBQ (Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)), a Class II device regulated under 21 CFR 868.1500. Datascope Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1993
Date Received
December 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class
Class II
Regulation Number
868.1500
Review Panel
AN
Submission Type

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  • 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 CBQ

  • K040917 — PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B (April 29, 2004)
  • K994188 — MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 (May 19, 2000)
  • K962648 — OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR (January 17, 1997)
  • K931439 — OHMEDA MODEL 5330 ANESTHETIC MONITOR (October 19, 1993)
  • K923433 — AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE (July 22, 1993)
  • K923276 — CAPNOMAC ULTIMA ANESTHESIA MONITOR (July 21, 1993)
  • K922876 — AS/3 COP MODULE (July 21, 1993)
  • K930303 — DATASCOPE MULTINEX ID PLUS (June 16, 1993)
  • K914295 — ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED (April 10, 1992)
  • K911644 — NGM FRAME (March 4, 1992)

FDA data resources