BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST

Accelerator, Linear, Medical

IT-V MEDIZINTECHNIK, GMBH

The following data is part of a premarket notification filed by It-v Medizintechnik, Gmbh with the FDA for Bellystep, Headstep, Breaststep, Prostep, Wingstep And Icast.

Pre-market Notification Details

• Device ID: K081218
• 510k Number: K081218
• Device Name: BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST
• Classification: Accelerator, Linear, Medical
• Applicant: IT-V MEDIZINTECHNIK, GMBH 56 WESTCOTT ROAD Stamford, CT 06902
• Contact: Cornelia Damsky
• Correspondent: Cornelia Damsky; IT-V MEDIZINTECHNIK, GMBH 56 WESTCOTT ROAD 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: 2008-04-30
• Decision Date: 2008-07-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
09120074396500	K081218	000
09120074396333	K081218	000
09120074396104	K081218	000
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