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510(k) K051869

NEOBLUE COZY LED PHOTOTHERAPY SYSTEM by Natus Medical, Inc. — Product Code LBI

K051869 is an FDA 510(k) premarket notification submitted by Natus Medical, Inc. for the device "NEOBLUE COZY LED PHOTOTHERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 7, 2005. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Natus Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2005
Date Received
July 11, 2005
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, Inc.

  • K093304 — PROTEKTOR 32 (August 11, 2010)
  • K093949 — OLYMPIC BRAINZ MONITOR MODEL OBM70001 (June 16, 2010)
  • K090019 — NATUS NEUROWORKS, MODEL 104196 (February 22, 2010)
  • K083371 — NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) (December 8, 2009)
  • K073665 — ALGO 5 NEWBORN HEARING SCREENER (January 25, 2008)
  • K030823 — ALGO 3I NEWBORN HEARING SCREENER (April 9, 2003)
  • K022196 — NATUS BLUE LIGHT PHOTOTHERAPY UNIT (September 19, 2002)
  • K013137 — ALGO 3 NEWBORN HEARING SCREENER (October 16, 2001)
  • K974805 — CO-STAT(TM) END TIDAL BREATH ANALYZER (March 11, 1998)
  • K935160 — MINIMUFFS (February 9, 1995)

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)

FDA data resources