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510(k) K813214

INFANT PHOTOTHERAPY MASK by Montrose Phototherapy Supply — Product Code FOK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1981
Date Received
November 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Neonatal Eye
Device Class
Class I
Regulation Number
880.5270
Review Panel
HO
Submission Type

Other clearances by Montrose Phototherapy Supply

  • K813188 — INFANT PHOTOTHERAPY LIGHT (December 9, 1981)

Other clearances for product code FOK

  • K962290 — DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER (July 3, 1996)
  • K926118 — LIFE TRACE(R) BILIRUBIN MASK (March 15, 1993)
  • K851918 — INFANT PHOTOTHERAPY MASK (June 7, 1985)
  • K840894 — PHOTO-THERAPY EYE PROTECTOR (March 23, 1984)