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FDA 510(k)

ACCU02 SYSTEM

K-Number: K051007 · 2005-06-16

ApplicantMiti Corp.
Decision Date2005-06-16
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ACCU02 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Miti Corp.. It received FDA 510(k) clearance on 2005-06-16 under 510(k) number K051007. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU02 SYSTEM?

ACCU02 SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-16. The listed applicant is Miti Corp.. The 510(k) number is K051007.

When did ACCU02 SYSTEM receive FDA 510(k) clearance?

ACCU02 SYSTEM received FDA 510(k) clearance on 2005-06-16, under 510(k) number K051007.

Who is the listed applicant for ACCU02 SYSTEM?

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

What is the FDA product code for ACCU02 SYSTEM?

The FDA product code for ACCU02 SYSTEM is NFB.

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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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