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510(k) K070795

SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM by Atcor Medical Pty, Ltd. — Product Code DSK

K070795 is an FDA 510(k) premarket notification submitted by Atcor Medical Pty, Ltd. for the device "SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on August 31, 2007. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Atcor Medical Pty, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2007
Date Received
March 22, 2007
Clearance Type
Traditional
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 Pty, Ltd.

  • K012487 — SPHYGMOCOR PX MODEL SCOR-PX (February 21, 2002)

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)
  • K080670 — MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (April 23, 2008)
  • 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