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510(k) K982279

VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 by Bci Intl., Inc. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1998
Date Received
June 30, 1998
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 Bci Intl., Inc.

  • K991410 — 3402 HANDHELD PULSE OXIMETER (June 9, 1999)
  • K991086 — CAPNOCHECK II, MODEL 8400 (June 9, 1999)
  • K984618 — BCI MINI-TORR PLUS, MODEL 6004 (March 25, 1999)
  • K983796 — 6004 NIBP MONITOR WITH TEMPERATURE (January 22, 1999)
  • K981939 — AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR (August 20, 1998)
  • K980714 — BCI 3401 HANDHELD PULSE OXIMETER (March 25, 1998)
  • K974697 — REUSABLE FINGER SENSOR 3444 (March 11, 1998)
  • K970801 — BCI MODEL 6004 NIBP MONITOR (6004) (November 12, 1997)
  • K970209 — CAPNOCHECK PLUS (April 18, 1997)
  • K963496 — OXI TEMP (November 26, 1996)

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