FDA 510(k)

MARZ-175

K-Number: K811199 · 1981-05-21

Decision Date1981-05-21

Product CodeCBT

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MARZ-175 is the device name listed in this FDA 510(k) record. The listed applicant is Emde Corp.. It received FDA 510(k) clearance on 1981-05-21 under 510(k) number K811199. The device is classified under product code CBT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARZ-175?

MARZ-175 is a medical device that received FDA 510(k) clearance on 1981-05-21. The listed applicant is Emde Corp.. The 510(k) number is K811199.

When did MARZ-175 receive FDA 510(k) clearance?

MARZ-175 received FDA 510(k) clearance on 1981-05-21, under 510(k) number K811199.

Who is the listed applicant for MARZ-175?

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

What is the FDA product code for MARZ-175?

The FDA product code for MARZ-175 is CBT.

Other records listing Emde Corp. 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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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.