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510(k) K926099

DATASCOPE 6000 MONITOR by Datascope Corp. — Product Code MLC

K926099 is an FDA 510(k) premarket notification submitted by Datascope Corp. for the device "DATASCOPE 6000 MONITOR". The FDA issued a decision of Substantially Equivalent on August 6, 1993. The device falls under product code MLC (Monitor, St Segment), a Class II device regulated under 21 CFR 870.2340. Datascope Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1993
Date Received
December 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, St Segment
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Datascope Corp.

  • K190884 — TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool (December 26, 2019)
  • K181122 — CARDIOSAVE Intra-Aortic Balloon Pump (May 31, 2018)
  • 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 MLC

  • K993826 — NARKOMED 6000 (March 23, 2000)

FDA data resources