ORION

Accelerator, Linear, Medical

CGR MEDICAL CORP.

The following data is part of a premarket notification filed by Cgr Medical Corp. with the FDA for Orion.

Pre-market Notification Details

• Device ID: K833941
• 510k Number: K833941
• Device Name: ORION
• Classification: Accelerator, Linear, Medical
• Applicant: CGR MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-11-15
• Decision Date: 1983-12-29