LULLABY

Unit, Neonatal Phototherapy

GE HEALTHCARE CLINICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Healthcare Clinical Systems with the FDA for Lullaby.

Pre-market Notification Details

• Device ID: K071828
• 510k Number: K071828
• Device Name: LULLABY
• Classification: Unit, Neonatal Phototherapy
• Applicant: GE HEALTHCARE CLINICAL SYSTEMS 8880 GORMAN ROAD Laurel, MD 20723
• Contact: Thalia Brine
• Correspondent: Thalia Brine; GE HEALTHCARE CLINICAL SYSTEMS 8880 GORMAN ROAD Laurel, MD 20723
• Product Code: LBI
• CFR Regulation Number: 880.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-07-03
• Decision Date: 2007-08-06
• Summary: summary