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510(k) K021531

RPI REPLACEMENT PHOTOTHERAPY LIGHTS by Replacement Parts Industries, Inc. — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2002
Date Received
May 10, 2002
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 Replacement Parts Industries, Inc.

  • K020966 — RPI REPLACEMENT HEATING ELEMENTS (June 13, 2002)
  • K020219 — RPI SKIN OR AIR TEMPERATURE PROBE (April 12, 2002)

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  • K160745 — neoBLUE compact LED Phototherapy System (December 12, 2016)