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510(k) K991086

CAPNOCHECK II, MODEL 8400 by Bci Intl., Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1999
Date Received
March 31, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

Other clearances by Bci Intl., Inc.

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  • K983796 — 6004 NIBP MONITOR WITH TEMPERATURE (January 22, 1999)
  • K982279 — VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 (September 25, 1998)
  • 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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