HEADFIX

Accelerator, Linear, Medical

MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH

The following data is part of a premarket notification filed by Medical Intelligence Medizintechnik Gmbh with the FDA for Headfix.

Pre-market Notification Details

• Device ID: K030439
• 510k Number: K030439
• Device Name: HEADFIX
• Classification: Accelerator, Linear, Medical
• Applicant: MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH 56 WESTCOTT RD. Stamford, CT 06902
• Contact: Cornelia Damsky
• Correspondent: Cornelia Damsky; MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH 56 WESTCOTT RD. Stamford, CT 06902
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-02-11
• Decision Date: 2003-05-08
• Summary: summary