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510(k) K983796

6004 NIBP MONITOR WITH TEMPERATURE by Bci Intl., Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1999
Date Received
October 27, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

Other clearances by Bci Intl., Inc.

  • K991086 — CAPNOCHECK II, MODEL 8400 (June 9, 1999)
  • K991410 — 3402 HANDHELD PULSE OXIMETER (June 9, 1999)
  • K984618 — BCI MINI-TORR PLUS, MODEL 6004 (March 25, 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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