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510(k) K910770

504US PULSE OXIMETER by Criticare Systems, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1991
Date Received
February 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
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)
  • K944860 — SCHOLAR PATIENT MONITOR (June 20, 1995)

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