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510(k) K924679

OXYCARE(TM) OXYGEN CONTROLLER/MONITOR by Air-Shields Vickers, Inc. — Product Code KLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1995
Date Received
September 16, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class
Class II
Regulation Number
868.2500
Review Panel
AN
Submission Type

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  • K903378 — MODEL C286 ISOLETTE INFANT INCUBATOR (October 15, 1990)
  • K895782 — NEONATAL INCUBATOR (ACCESSORY) (December 7, 1989)
  • K884086 — C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR (November 14, 1988)

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  • K870805 — MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR (May 27, 1987)
  • K861861 — 515A NEO-TRAK NEONATAL MONITOR (July 10, 1986)
  • K860124 — HORIZON 2000 TRANSCUTANEOUS GAS MONITORING (May 9, 1986)
  • K860951 — KONTRON CUTANEOUS PO2 MONITOR 820 (April 9, 1986)