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FDA 510(k)

Y-ADAPTER

K-Number: K082174 · 2008-10-20

Decision Date2008-10-20
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Y-ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Asthmatx, Inc.. It received FDA 510(k) clearance on 2008-10-20 under 510(k) number K082174. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Y-ADAPTER?

Y-ADAPTER is a medical device that received FDA 510(k) clearance on 2008-10-20. The listed applicant is Asthmatx, Inc.. The 510(k) number is K082174.

When did Y-ADAPTER receive FDA 510(k) clearance?

Y-ADAPTER received FDA 510(k) clearance on 2008-10-20, under 510(k) number K082174.

Who is the listed applicant for Y-ADAPTER?

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

What is the FDA product code for Y-ADAPTER?

The FDA product code for Y-ADAPTER is KTI.

Related Clinical Trials

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.

Related Devices (Code: KTI)

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.

Official Source

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