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510(k) K874198

VITALOG HMS-3000 by Vitalog Corp. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1988
Date Received
October 9, 1987
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 Vitalog Corp.

  • K871813 — VITALOG PMS-8 (MODIFICATION) (November 23, 1987)
  • K845051 — VITALOG PMS-8 (May 15, 1985)
  • K812739 — VITALOG PMS-8 MONITOR (December 29, 1981)

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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)