Home / 510(k) Clearances / K033738

510(k) K033738

MONITORING SYSTEM, MODEL ARGUS PB-2200 by Schiller AG — Product Code DSK

K033738 is an FDA 510(k) premarket notification submitted by Schiller AG for the device "MONITORING SYSTEM, MODEL ARGUS PB-2200". The FDA issued a decision of Substantially Equivalent on August 24, 2004. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Schiller AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2004
Date Received
November 28, 2003
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 Schiller AG

  • K221056 — ARGUS PB-3000 (July 6, 2023)
  • K183425 — CARDIOVIT AT-102 G2 (March 2, 2020)
  • K170182 — CARDIOVIT FT-1 (July 19, 2017)
  • K152043 — Diagnostic Station DS20 (May 6, 2016)
  • K101619 — WELCH ALLYN 1500 PATIENT MONITOR (November 12, 2010)
  • K063814 — BP-200 PLUS (March 7, 2007)
  • K053207 — ARGUS, MODEL LCM (May 19, 2006)
  • K051368 — BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM (August 9, 2005)
  • K050686 — CARDIOVIT AT-10PLUS (May 4, 2005)
  • K031557 — CARDIOVIT AT-102 (April 14, 2004)

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)
  • K070795 — SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (August 31, 2007)
  • 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