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510(k) K010770

BCI ADVISOR VITAL SIGNS MONITOR (9200) by Bci, Inc. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2001
Date Received
March 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Bci, Inc.

  • K030407 — ADVISOR, MODEL 9200 (August 19, 2003)
  • K031742 — BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER (August 18, 2003)
  • K020739 — BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR (June 3, 2002)
  • K020350 — BCI 3180 PULSE OXIMETER (April 30, 2002)
  • K013862 — BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM (February 21, 2002)
  • K013171 — 3420 DIGIT PULSE OXIMETER, MODEL 3420 (January 3, 2002)
  • K011156 — BCI 3403 SLEEP SCREENING PULSE OXIMETER (June 14, 2001)
  • K011177 — BCI ADVISOR VITAL SIGNS MONITOR (9200) (May 23, 2001)
  • K001770 — BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A (July 5, 2000)
  • K944121 — SHARPS CONTAINER 18 GALLON (January 27, 1995)

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