FDA 510(k)

NORAS MR-BI320-PA 3T

K-Number: K082373 · 2008-08-29

Decision Date2008-08-29

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NORAS MR-BI320-PA 3T 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 2008-08-29 under 510(k) number K082373. 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 MR-BI320-PA 3T?

NORAS MR-BI320-PA 3T is a medical device that received FDA 510(k) clearance on 2008-08-29. The listed applicant is Noras Mri Products GmbH. The 510(k) number is K082373.

When did NORAS MR-BI320-PA 3T receive FDA 510(k) clearance?

NORAS MR-BI320-PA 3T received FDA 510(k) clearance on 2008-08-29, under 510(k) number K082373.

Who is the listed applicant for NORAS MR-BI320-PA 3T?

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 MR-BI320-PA 3T?

The FDA product code for NORAS MR-BI320-PA 3T is MOS.

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Other records listing Noras Mri Products GmbH as applicant

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Related Devices (Code: 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.