ACCULITE

Monitor, Patient Position, Light-beam

MEDICAL ALIGNMENT SYSTEMS

The following data is part of a premarket notification filed by Medical Alignment Systems with the FDA for Acculite.

Pre-market Notification Details

• Device ID: K872841
• 510k Number: K872841
• Device Name: ACCULITE
• Classification: Monitor, Patient Position, Light-beam
• Applicant: MEDICAL ALIGNMENT SYSTEMS 9160 SOUTH 300 WEST, BLDG. 1, STE19 Sandy, UT 84070
• Contact: Deborah S Stout
• Correspondent: Deborah S Stout; MEDICAL ALIGNMENT SYSTEMS 9160 SOUTH 300 WEST, BLDG. 1, STE19 Sandy, UT 84070
• Product Code: IWE
• CFR Regulation Number: 892.5780 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-07-20
• Decision Date: 1987-08-12