FDA 510(k)

NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230

K-Number: K091546 · 2009-06-24

Decision Date2009-06-24

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 is the device name listed in this FDA 510(k) record. The listed applicant is Noras Mri Products GmbH. It received FDA 510(k) clearance on 2009-06-24 under 510(k) number K091546. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230?

NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 is a medical device that received FDA 510(k) clearance on 2009-06-24. The listed applicant is Noras Mri Products GmbH. The 510(k) number is K091546.

When did NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 receive FDA 510(k) clearance?

NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 received FDA 510(k) clearance on 2009-06-24, under 510(k) number K091546.

Who is the listed applicant for NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230?

The FDA 510(k) record lists Noras Mri Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230?

The FDA product code for NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 is MOS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.