NeoBLUE® LED Phototherapy System

Unit, Neonatal Phototherapy

Natus Medical Incorporated

The following data is part of a premarket notification filed by Natus Medical Incorporated with the FDA for Neoblue® Led Phototherapy System.

Pre-market Notification Details

• Device ID: K160305
• 510k Number: K160305
• Device Name: NeoBLUE® LED Phototherapy System
• Classification: Unit, Neonatal Phototherapy
• Applicant: Natus Medical Incorporated 5900 First Avenue South Seattle, WA 98108
• Contact: Judy Buckham
• Correspondent: Judy Buckham; Natus Medical Incorporated 5900 First Avenue South Seattle, WA 98108
• Product Code: LBI
• CFR Regulation Number: 880.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-04
• Decision Date: 2016-05-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382830011594	K160305	000