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510(k) K924297

DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER by Air-Shields Vickers, Inc. — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1993
Date Received
August 26, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal
Device Class
Class II
Regulation Number
880.5400
Review Panel
HO
Submission Type

Other clearances by Air-Shields Vickers, Inc.

  • K924679 — OXYCARE(TM) OXYGEN CONTROLLER/MONITOR (February 21, 1995)
  • K912908 — AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM (December 13, 1991)
  • K912909 — SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM (November 5, 1991)
  • K912910 — C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM (October 30, 1991)
  • K904691 — AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST (February 19, 1991)
  • 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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