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510(k) K980714

BCI 3401 HANDHELD PULSE OXIMETER by Bci Intl., Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1998
Date Received
February 24, 1998
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 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)
  • K982279 — VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 (September 25, 1998)
  • K981939 — AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR (August 20, 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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  • K253109 — Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) (January 7, 2026)
  • K251751 — Spo2 Sensor CSS032D (December 19, 2025)
  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
  • K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusa (December 1, 2025)
  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
  • K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso (November 18, 2025)
  • K250837 — Pulse Oximeter (September 25, 2025)