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510(k) K160745

neoBLUE compact LED Phototherapy System by Natus Medical Incorporated — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2016
Date Received
March 18, 2016
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 Natus Medical Incorporated

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  • K143440 — Natus Quantum (April 20, 2015)
  • K141446 — ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO H (August 22, 2014)
  • K112247 — A BAER WITH ABAER I/O FUNCTION (April 2, 2012)
  • K111618 — AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION (December 28, 2011)
  • K103589 — NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM (May 13, 2011)
  • K100683 — NEUROLINK IP MODEL: PK1117 (April 9, 2010)

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)
  • K160238 — Airborne Phototherapy Light (June 14, 2016)