BRAINLAB MASK SYSTEM

Accelerator, Linear, Medical

BRAINLAB MED. COMPUTERSYSTEME GMBH

The following data is part of a premarket notification filed by Brainlab Med. Computersysteme Gmbh with the FDA for Brainlab Mask System.

Pre-market Notification Details

• Device ID: K945903
• 510k Number: K945903
• Device Name: BRAINLAB MASK SYSTEM
• Classification: Accelerator, Linear, Medical
• Applicant: BRAINLAB MED. COMPUTERSYSTEME GMBH GRUBER STRABE 46C 85586 Poing/munchen, DE 85586
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-12-02
• Decision Date: 1995-06-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056481004071	K945903	000
04056481125967	K945903	000