IDENTIFY

Accelerator, Linear, Medical

HUMEDIQ GMBH

The following data is part of a premarket notification filed by Humediq Gmbh with the FDA for Identify.

Pre-market Notification Details

• Device ID: K112692
• 510k Number: K112692
• Device Name: IDENTIFY
• Classification: Accelerator, Linear, Medical
• Applicant: HUMEDIQ GMBH BAHNHOFSTRABE 108 Grafelfing, DE 82166
• Contact: Moritz Hoyer
• Correspondent: Moritz Hoyer; HUMEDIQ GMBH BAHNHOFSTRABE 108 Grafelfing, DE 82166
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-09-15
• Decision Date: 2012-08-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EHUQHQ0100707	K112692	000