510(k) K142416

Luma Wrap by Salter Labs — Product Code PDH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 12, 2015
Date Received: August 28, 2014
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Blanket, Neonatal Phototherapy
Device Class: Class II
Regulation Number: 880.5700
Review Panel: HO
Submission Type

Is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting.

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510(k) K142416

Clearance Details

Device Classification

Other clearances by Salter Labs

Other clearances for product code PDH