FDA 510(k)

myTAP2

K-Number: K181482 · 2018-08-31

Decision Date2018-08-31

Product CodeLRK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

myTAP2 is the device name listed in this FDA 510(k) record. The listed applicant is Airway Management, Inc.. It received FDA 510(k) clearance on 2018-08-31 under 510(k) number K181482. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the myTAP2?

myTAP2 is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is Airway Management, Inc.. The 510(k) number is K181482.

When did myTAP2 receive FDA 510(k) clearance?

myTAP2 received FDA 510(k) clearance on 2018-08-31, under 510(k) number K181482.

Who is the listed applicant for myTAP2?

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

What is the FDA product code for myTAP2?

The FDA product code for myTAP2 is LRK.

Other records listing Airway Management, 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.

K160239TAP 3, TAP 1

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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.