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510(k) K221056

ARGUS PB-3000 by Schiller AG — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2023
Date Received
April 11, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Schiller AG

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  • 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)
  • K033738 — MONITORING SYSTEM, MODEL ARGUS PB-2200 (August 24, 2004)
  • K031557 — CARDIOVIT AT-102 (April 14, 2004)

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  • K251702 — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4 (November 10, 2025)
  • K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550 (October 17, 2025)
  • K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); (September 2, 2025)
  • K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (July 29, 2025)
  • K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (July 9, 2025)
  • K250757 — Radius VSM and Accessories (May 29, 2025)
  • K242962 — Telemetry Monitor 5500 Release 4.0 (867232) (May 5, 2025)