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510(k) K953817

ARISTO MEDICAL MODEL 2101 PATIENT MONITOR by Aristo Medical Products, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1995
Date Received
August 14, 1995
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)
  • K920966 — SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT) (July 16, 1993)

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