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510(k) K882291

RETROFIT BABY FACE SHIELD (RFS) by Physician Engineered Products, Inc. — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1988
Date Received
June 1, 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 Physician Engineered Products, Inc.

  • K110550 — BRIGHT EMBRACE MODEL SBL60 (February 3, 2012)
  • K093618 — BILI-MIRROR MODEL BLM-1 (April 23, 2010)
  • K974830 — ULTRA BILI LIGHT (May 20, 1998)
  • K883818 — MODIFIED REFLUX REDUCER (November 21, 1988)
  • K882278 — RESUSCITATION BAG CONTROLLER (RBC) (June 16, 1988)
  • K873700 — INSTITUTIONAL BILI LIGHT (IBL) (December 11, 1987)
  • K850599 — HOME BILI LIGHTS-MODEL 100 (June 17, 1985)

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)