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510(k) K924170

ISOLETTE INCUBATOR HUMIDITY METER by Air-Shields, Inc. — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1993
Date Received
August 19, 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

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  • K960980 — ISOLETTE INFANT INCUBATOR (July 30, 1996)
  • K924709 — SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE (January 17, 1996)
  • K940951 — RW RESUCITAIRE INFANT RADIANT WARMER (May 3, 1995)
  • K940975 — C450/C400 INFANT INCUBATORS (June 23, 1994)
  • K941106 — MODEL TI500 ISOLETTE INFANT INCUBATOR (June 10, 1994)
  • K922150 — EXAMINATION LAMP (July 21, 1992)
  • K914864 — MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR (March 13, 1992)

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