RPI REPLACEMENT PHOTOTHERAPY LIGHTS

Unit, Neonatal Phototherapy

REPLACEMENT PARTS INDUSTRIES, INC.

The following data is part of a premarket notification filed by Replacement Parts Industries, Inc. with the FDA for Rpi Replacement Phototherapy Lights.

Pre-market Notification Details

• Device ID: K021531
• 510k Number: K021531
• Device Name: RPI REPLACEMENT PHOTOTHERAPY LIGHTS
• Classification: Unit, Neonatal Phototherapy
• Applicant: REPLACEMENT PARTS INDUSTRIES, INC. P.O. BOX 5019 Chatsworth, CA 91313 -5019
• Contact: Ira Lapides
• Correspondent: Ira Lapides; REPLACEMENT PARTS INDUSTRIES, INC. P.O. BOX 5019 Chatsworth, CA 91313 -5019
• Product Code: LBI
• CFR Regulation Number: 880.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-05-10
• Decision Date: 2002-05-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841034134589	K021531	000
00841034134572	K021531	000
00841034114062	K021531	000
00841034114055	K021531	000
00841034114048	K021531	000
00841034114031	K021531	000
00841034114024	K021531	000
00841034114000	K021531	000