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FDA 510(k)

TECA. MILLENNIUM

K-Number: K965065 · 1997-06-20

ApplicantMedelec , Ltd.
Decision Date1997-06-20
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TECA. MILLENNIUM is the device name listed in this FDA 510(k) record. The listed applicant is Medelec , Ltd.. It received FDA 510(k) clearance on 1997-06-20 under 510(k) number K965065. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECA. MILLENNIUM?

TECA. MILLENNIUM is a medical device that received FDA 510(k) clearance on 1997-06-20. The listed applicant is Medelec , Ltd.. The 510(k) number is K965065.

When did TECA. MILLENNIUM receive FDA 510(k) clearance?

TECA. MILLENNIUM received FDA 510(k) clearance on 1997-06-20, under 510(k) number K965065.

Who is the listed applicant for TECA. MILLENNIUM?

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

What is the FDA product code for TECA. MILLENNIUM?

The FDA product code for TECA. MILLENNIUM is GWF.

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Other records listing Medelec , Ltd. as applicant

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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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