COMPASS

Accelerator, Linear, Medical

SCANDITRONIX WELLHOFER GMBH

The following data is part of a premarket notification filed by Scanditronix Wellhofer Gmbh with the FDA for Compass.

Pre-market Notification Details

• Device ID: K072374
• 510k Number: K072374
• Device Name: COMPASS
• Classification: Accelerator, Linear, Medical
• Applicant: SCANDITRONIX WELLHOFER GMBH BAHNOFSTRASSE 5 Schwarzenbruck, DE 90592
• Contact: Martin Arold
• Correspondent: Martin Arold; SCANDITRONIX WELLHOFER GMBH BAHNOFSTRASSE 5 Schwarzenbruck, DE 90592
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-08-23
• Decision Date: 2007-12-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EIBAE30655000	K072374	000
EIBAE30620281	K072374	000
EIBAE30620271	K072374	000
EIBAE30620251	K072374	000
EIBAE30620241	K072374	000
EIBAE30620211	K072374	000
EIBAE30620201	K072374	000
EIBAE30300121	K072374	000
EIBAE30300101	K072374	000