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FDA 510(k)

Accurett

K-Number: K161615 · 2016-08-23

ApplicantH&O Equipments, Nv/Sa
Decision Date2016-08-23
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Accurett is the device name listed in this FDA 510(k) record. The listed applicant is H&O Equipments, Nv/Sa. It received FDA 510(k) clearance on 2016-08-23 under 510(k) number K161615. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Accurett?

Accurett is a medical device that received FDA 510(k) clearance on 2016-08-23. The listed applicant is H&O Equipments, Nv/Sa. The 510(k) number is K161615.

When did Accurett receive FDA 510(k) clearance?

Accurett received FDA 510(k) clearance on 2016-08-23, under 510(k) number K161615.

Who is the listed applicant for Accurett?

The FDA 510(k) record lists H&O Equipments, Nv/Sa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accurett?

The FDA product code for Accurett is GEH.

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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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