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510(k) K813188

INFANT PHOTOTHERAPY LIGHT by Montrose Phototherapy Supply — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1981
Date Received
November 16, 1981
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

Other clearances by Montrose Phototherapy Supply

  • K813214 — INFANT PHOTOTHERAPY MASK (December 9, 1981)

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  • K200031 — Neonatal Phototherapy System (October 5, 2020)
  • K190899 — bili-hut (September 5, 2019)
  • K182178 — neoBLUE blanket LED Phototherapy System (December 13, 2018)
  • K172656 — BiliLux (May 1, 2018)
  • K170585 — Skylife (October 27, 2017)
  • K163526 — Bilicocoon™ Phototherapy System (October 6, 2017)
  • K160745 — neoBLUE compact LED Phototherapy System (December 12, 2016)