CENTRALITE

Monitor, Patient Position, Light-beam

DIACOR, INC.

The following data is part of a premarket notification filed by Diacor, Inc. with the FDA for Centralite.

Pre-market Notification Details

• Device ID: K872489
• 510k Number: K872489
• Device Name: CENTRALITE
• Classification: Monitor, Patient Position, Light-beam
• Applicant: DIACOR, INC. 3191 SOUTH 3300 EAST, SUITE 100-A Salt Lake City, UT 84109
• Contact: Glenn N Waterman
• Correspondent: Glenn N Waterman; DIACOR, INC. 3191 SOUTH 3300 EAST, SUITE 100-A Salt Lake City, UT 84109
• Product Code: IWE
• CFR Regulation Number: 892.5780 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-06-23
• Decision Date: 1987-07-15