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510(k) K883779

WALLABY(TM) BLANKET by Fiberoptic Medical Products, Inc. — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1988
Date Received
September 6, 1988
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 Fiberoptic Medical Products, Inc.

  • K944686 — FIBEROPTIC LARYNGOSCOPE HANDLE (November 4, 1994)
  • K933598 — ENDOSTAR(TM) STYLET (January 25, 1994)
  • K921393 — IMAGICA MICRO-ENDOSCOPE (August 20, 1992)
  • K912252 — INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT (June 27, 1991)

Other clearances for product code LBI

  • K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) (January 15, 2026)
  • K243372 — BiliWrap (May 29, 2025)
  • K210289 — Infant Phototherapy Equipment (May 28, 2021)
  • 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)