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510(k) K080670

MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM by Atcor Medical — Product Code DSK

K080670 is an FDA 510(k) premarket notification submitted by Atcor Medical for the device "MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on April 23, 2008. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Atcor Medical has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2008
Date Received
March 10, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Blood-Pressure
Device Class
Class II
Regulation Number
870.1110
Review Panel
CV
Submission Type

Other clearances by Atcor Medical

  • K221742 — CONNEQT PULSE (April 21, 2023)
  • K122129 — SPHYGMOCOR XCEL (November 16, 2012)

Other clearances for product code DSK

  • K231586 — Endophys Blood Pressure Monitor model BPM-30 (November 3, 2023)
  • K160945 — Endophys Blood Pressure Monitor (September 26, 2016)
  • K152582 — CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box (December 3, 2015)
  • K141615 — ENDOPHYS BLOOD PRESSURE MONITOR (January 7, 2015)
  • K070795 — SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (August 31, 2007)
  • K033738 — MONITORING SYSTEM, MODEL ARGUS PB-2200 (August 24, 2004)
  • K021517 — ABP FOR WINDOWS (July 24, 2002)
  • K013943 — RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 (December 18, 2001)
  • K011865 — ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION (July 31, 2001)
  • K003122 — SMARTFLOW, MODEL SFIP 2000 (May 14, 2001)

FDA data resources