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FDA 510(k)

Aingeal Activity System

K-Number: K153275 · 2016-02-26

ApplicantIntelesens, Ltd.
Decision Date2016-02-26
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aingeal Activity System is the device name listed in this FDA 510(k) record. The listed applicant is Intelesens, Ltd.. It received FDA 510(k) clearance on 2016-02-26 under 510(k) number K153275. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aingeal Activity System?

Aingeal Activity System is a medical device that received FDA 510(k) clearance on 2016-02-26. The listed applicant is Intelesens, Ltd.. The 510(k) number is K153275.

When did Aingeal Activity System receive FDA 510(k) clearance?

Aingeal Activity System received FDA 510(k) clearance on 2016-02-26, under 510(k) number K153275.

Who is the listed applicant for Aingeal Activity System?

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

What is the FDA product code for Aingeal Activity System?

The FDA product code for Aingeal Activity System is MHX.

Related Devices (Code: MHX)

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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