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510(k) K971256

DUO-LITE PHOTOTHERAPY SYSTEM by Air-Shields, Inc. — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1997
Date Received
April 4, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Neonatal Phototherapy
Device Class
Class II
Regulation Number
880.5700
Review Panel
HO
Submission Type

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  • 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)
  • K924170 — ISOLETTE INCUBATOR HUMIDITY METER (February 5, 1993)
  • K922150 — EXAMINATION LAMP (July 21, 1992)
  • K914864 — MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR (March 13, 1992)

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