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510(k) K862798

MINIOX 100 PULSE OXIMETER by Catalyst Research Corp. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1986
Date Received
July 23, 1986
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.

  • K905310 — MINIOX V PULSE OXIMETER (May 28, 1991)
  • K874132 — MINIOX IV PORTABLE PULSE OXIMETER (January 19, 1988)
  • 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)
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  • K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable (August 13, 2025)