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FDA 510(k)

WIN-1 TANGO

K-Number: K000204 · 2000-08-01

ApplicantDuracare Medical Equipment, L.C.
Decision Date2000-08-01
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WIN-1 TANGO is the device name listed in this FDA 510(k) record. The listed applicant is Duracare Medical Equipment, L.C.. It received FDA 510(k) clearance on 2000-08-01 under 510(k) number K000204. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WIN-1 TANGO?

WIN-1 TANGO is a medical device that received FDA 510(k) clearance on 2000-08-01. The listed applicant is Duracare Medical Equipment, L.C.. The 510(k) number is K000204.

When did WIN-1 TANGO receive FDA 510(k) clearance?

WIN-1 TANGO received FDA 510(k) clearance on 2000-08-01, under 510(k) number K000204.

Who is the listed applicant for WIN-1 TANGO?

The FDA 510(k) record lists Duracare Medical Equipment, L.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WIN-1 TANGO?

The FDA product code for WIN-1 TANGO is ITI.

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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.

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