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510(k) K905310

MINIOX V PULSE OXIMETER by Catalyst Research Corp. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1991
Date Received
November 28, 1990
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 Catalyst Research Corp.

  • K874132 — MINIOX IV PORTABLE PULSE OXIMETER (January 19, 1988)
  • K862798 — MINIOX 100 PULSE OXIMETER (August 28, 1986)
  • K833995 — MINI OX II (December 12, 1983)
  • K833326 — MINI OX III OXYGEN MONITOR (November 3, 1983)
  • K790784 — MODEL M25R, OXYGEN ANALYZER (April 27, 1979)
  • K790785 — MODEL M25RL, (CRC) OXYGEN ANALYZER (April 27, 1979)
  • K782062 — ANALYZER, OXYGEN MODEL M25RA & M25RAD (February 15, 1979)
  • K781746 — MINICO (December 5, 1978)

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  • 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)