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FDA 510(k)

MITEK CUFFTACK

K-Number: K003076 · 2000-10-27

ApplicantMitek Products
Decision Date2000-10-27
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MITEK CUFFTACK is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Products. It received FDA 510(k) clearance on 2000-10-27 under 510(k) number K003076. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MITEK CUFFTACK?

MITEK CUFFTACK is a medical device that received FDA 510(k) clearance on 2000-10-27. The listed applicant is Mitek Products. The 510(k) number is K003076.

When did MITEK CUFFTACK receive FDA 510(k) clearance?

MITEK CUFFTACK received FDA 510(k) clearance on 2000-10-27, under 510(k) number K003076.

Who is the listed applicant for MITEK CUFFTACK?

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

What is the FDA product code for MITEK CUFFTACK?

The FDA product code for MITEK CUFFTACK is MAI.

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Other records listing Mitek Products 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

View on FDA Database →

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

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