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510(k) K884133

PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP by Preemicare Corp. — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1989
Date Received
September 30, 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 Preemicare Corp.

  • K911450 — INFANT VENTILATOR (June 18, 1991)
  • K896375 — PREEMICARE NEBUTECH NEBULIZER SYSTEM (October 29, 1990)
  • K900735 — MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR (May 2, 1990)
  • K893622 — PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL. (January 3, 1990)
  • K893624 — PREEMICARE MODEL 2500 TRANSPORT WARMER (September 27, 1989)
  • K891674 — NEONATAL ENVIRONMENTAL MONITOR, MODEL 275 (August 31, 1989)
  • K885350 — PREEMICARE SERIES 2000 INFANT WARMER (August 7, 1989)
  • K881476 — PREEMICARE MODEL D1-X1, SERIES 3000 (December 8, 1988)

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)