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510(k) K944860

SCHOLAR PATIENT MONITOR by Criticare Systems, Inc. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1995
Date Received
October 3, 1994
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 Criticare Systems, Inc.

  • K101602 — VITAL SIGNS MONITOR (September 1, 2010)
  • K091050 — 506CN PATIENT MONITOR (May 27, 2009)
  • K042569 — 8600 VITAL SIGNS MONITOR (September 29, 2004)
  • K030613 — VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 (April 17, 2003)
  • K022435 — 507EL VITAL SIGNS MONITOR (August 14, 2002)
  • K012059 — 8100/8500 VITAL SIGNS MONITOR (August 1, 2001)
  • K001020 — 8100 VITAL SIGNS MONITOR (April 28, 2000)
  • K000276 — MPT 24 AND VITAL VIEW 24 (March 1, 2000)
  • K961223 — MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS (December 10, 1996)
  • K942737 — POET IQ WITH FIVE AGENT CAPABILITY (February 9, 1995)

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  • K250757 — Radius VSM and Accessories (May 29, 2025)
  • K242962 — Telemetry Monitor 5500 Release 4.0 (867232) (May 5, 2025)