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FDA 510(k)

eco-x Series (eco-x, eco-x-s)

K-Number: K211159 · 2021-12-30

Decision Date2021-12-30
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

eco-x Series (eco-x, eco-x-s) is the device name listed in this FDA 510(k) record. The listed applicant is Hdx Will Corp.. It received FDA 510(k) clearance on 2021-12-30 under 510(k) number K211159. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eco-x Series (eco-x, eco-x-s)?

eco-x Series (eco-x, eco-x-s) is a medical device that received FDA 510(k) clearance on 2021-12-30. The listed applicant is Hdx Will Corp.. The 510(k) number is K211159.

When did eco-x Series (eco-x, eco-x-s) receive FDA 510(k) clearance?

eco-x Series (eco-x, eco-x-s) received FDA 510(k) clearance on 2021-12-30, under 510(k) number K211159.

Who is the listed applicant for eco-x Series (eco-x, eco-x-s)?

The FDA 510(k) record lists Hdx Will Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eco-x Series (eco-x, eco-x-s)?

The FDA product code for eco-x Series (eco-x, eco-x-s) is OAS.

Other records listing Hdx Will Corp. 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.

View all 9 devices →

Related Devices (Code: OAS)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.