FDA 510(k)

CS-MAG II

K-Number: K121825 · 2013-03-11

Decision Date2013-03-11

Product CodeDPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CS-MAG II is the device name listed in this FDA 510(k) record. The listed applicant is Biomagnetik-Park GmbH. It received FDA 510(k) clearance on 2013-03-11 under 510(k) number K121825. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CS-MAG II?

CS-MAG II is a medical device that received FDA 510(k) clearance on 2013-03-11. The listed applicant is Biomagnetik-Park GmbH. The 510(k) number is K121825.

When did CS-MAG II receive FDA 510(k) clearance?

CS-MAG II received FDA 510(k) clearance on 2013-03-11, under 510(k) number K121825.

Who is the listed applicant for CS-MAG II?

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

What is the FDA product code for CS-MAG II?

The FDA product code for CS-MAG II is DPS.

Related Devices (Code: DPS)

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.