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FDA 510(k)

WIN-2 TANGO ELITE NP

K-Number: K013361 · 2002-02-26

ApplicantDurable Medical Equipment, Inc.
Decision Date2002-02-26
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WIN-2 TANGO ELITE NP is the device name listed in this FDA 510(k) record. The listed applicant is Durable Medical Equipment, Inc.. It received FDA 510(k) clearance on 2002-02-26 under 510(k) number K013361. 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-2 TANGO ELITE NP?

WIN-2 TANGO ELITE NP is a medical device that received FDA 510(k) clearance on 2002-02-26. The listed applicant is Durable Medical Equipment, Inc.. The 510(k) number is K013361.

When did WIN-2 TANGO ELITE NP receive FDA 510(k) clearance?

WIN-2 TANGO ELITE NP received FDA 510(k) clearance on 2002-02-26, under 510(k) number K013361.

Who is the listed applicant for WIN-2 TANGO ELITE NP?

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

What is the FDA product code for WIN-2 TANGO ELITE NP?

The FDA product code for WIN-2 TANGO ELITE NP is ITI.

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Other records listing Durable Medical Equipment, Inc. 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.

K934297DURABLE MEDICAL EQUIPMENT COMPANY, STANDARD MECHANICAL WHEELCHAIR

Related Devices (Code: ITI)

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.

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