Home / 510(k) Clearances / K941351

510(k) K941351

BURDICK PRO2 OXIMETER by Burdick Corp. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1994
Date Received
March 22, 1994
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 Burdick Corp.

  • K952417 — QUEST EXERCISE STRESS SYSTEM (May 22, 1996)
  • K954267 — BURDICK 200 PULSE OXIMETER (May 3, 1996)
  • K946281 — ECLIPSE 4 ELECTROCARDIOGRAPH (April 23, 1996)
  • K945985 — PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 (July 3, 1995)
  • K943959 — ECLIPSE 4 ELECTROCARDIOGRAPH (May 17, 1995)
  • K942565 — ALTAIR-DISC RECORDER (December 5, 1994)
  • K942438 — ALTAIR 6100 CASSETTE RECORDER (August 5, 1994)
  • K903565 — E560 ELECTROCARDIOGRAPH (July 24, 1991)
  • K904032 — ELITE II ELECTROCARDIOGRAPH (July 24, 1991)
  • K900729 — NEOSERV 824 (June 8, 1990)

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)