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FDA 510(k)

31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil

K-Number: K213480 · 2023-02-01

ApplicantRapid Biomedical GmbH
Decision Date2023-02-01
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Biomedical GmbH. It received FDA 510(k) clearance on 2023-02-01 under 510(k) number K213480. 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 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil?

31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil is a medical device that received FDA 510(k) clearance on 2023-02-01. The listed applicant is Rapid Biomedical GmbH. The 510(k) number is K213480.

When did 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil receive FDA 510(k) clearance?

31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil received FDA 510(k) clearance on 2023-02-01, under 510(k) number K213480.

Who is the listed applicant for 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil?

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

What is the FDA product code for 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil?

The FDA product code for 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil is MOS.

Other records listing Rapid Biomedical GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MOS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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