DIOLASE

Monitor, Patient Position, Light-beam

SCANDITRONIX, INC.

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

Pre-market Notification Details

• Device ID: K904753
• 510k Number: K904753
• Device Name: DIOLASE
• Classification: Monitor, Patient Position, Light-beam
• Applicant: SCANDITRONIX, INC. HUSBYBORG, S-752 29 UPPSALA Sweden, SE
• Contact: Lennart Ward
• Correspondent: Lennart Ward; SCANDITRONIX, INC. HUSBYBORG, S-752 29 UPPSALA Sweden, SE
• Product Code: IWE
• CFR Regulation Number: 892.5780 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-10-19
• Decision Date: 1990-11-09