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510(k) K920966

SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT) by Aristo Medical Products, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1993
Date Received
March 2, 1992
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 Aristo Medical Products, Inc.

  • K961060 — ARISTO ESOPHAGEAL STETHOSCOPE (June 19, 1996)
  • K960251 — COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FIN (March 26, 1996)
  • K953817 — ARISTO MEDICAL MODEL 2101 PATIENT MONITOR (November 22, 1995)

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  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
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  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
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