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510(k) K011156

BCI 3403 SLEEP SCREENING PULSE OXIMETER by Bci, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2001
Date Received
April 16, 2001
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, 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)
  • K010770 — BCI ADVISOR VITAL SIGNS MONITOR (9200) (June 12, 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)

Other clearances for product code DQA

  • K252448 — AViTA Pulse Oximeter (SP61) (February 27, 2026)
  • K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (February 17, 2026)
  • K253109 — Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) (January 7, 2026)
  • K251751 — Spo2 Sensor CSS032D (December 19, 2025)
  • K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusa (December 1, 2025)
  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
  • K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso (November 18, 2025)
  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
  • K250837 — Pulse Oximeter (September 25, 2025)
  • K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable (August 13, 2025)