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510(k) K091050

506CN PATIENT MONITOR by Criticare Systems, Inc. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2009
Date Received
April 13, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Criticare Systems, Inc.

  • K101602 — VITAL SIGNS MONITOR (September 1, 2010)
  • 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)
  • K944860 — SCHOLAR PATIENT MONITOR (June 20, 1995)
  • K942737 — POET IQ WITH FIVE AGENT CAPABILITY (February 9, 1995)

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