NORAS MR-BI320-PA 1.5T

Coil, Magnetic Resonance, Specialty

NORAS MRI PRODUCTS GMBH

The following data is part of a premarket notification filed by Noras Mri Products Gmbh with the FDA for Noras Mr-bi320-pa 1.5t.

Pre-market Notification Details

• Device ID: K081118
• 510k Number: K081118
• Device Name: NORAS MR-BI320-PA 1.5T
• Classification: Coil, Magnetic Resonance, Specialty
• Applicant: NORAS MRI PRODUCTS GMBH LEIBNITZSTRASSE 4 Hoechberg, DE 97204
• Contact: Martin Hempel
• Correspondent: Stefan Preiss; TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891
• Product Code: MOS
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2008-04-21
• Decision Date: 2008-05-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04251269207266	K081118	000
04251269201578	K081118	000
04251269201585	K081118	000
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04251269202087	K081118	000
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04251269205279	K081118	000