FDA 510(k)

EBERLE Shaver System C3 and Accessories

K-Number: K193608 · 2021-01-15

Decision Date2021-01-15

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EBERLE Shaver System C3 and Accessories is a medical device manufactured by Eberle GmbH & Co. KG. It received FDA 510(k) clearance on 2021-01-15 under approval number K193608. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBERLE Shaver System C3 and Accessories?

EBERLE Shaver System C3 and Accessories is a medical device that received FDA 510(k) clearance on 2021-01-15. It is manufactured by Eberle GmbH & Co. KG. The 510(k) number is K193608.

When was EBERLE Shaver System C3 and Accessories approved by the FDA?

EBERLE Shaver System C3 and Accessories received FDA 510(k) clearance on 2021-01-15, under approval number K193608.

What company makes EBERLE Shaver System C3 and Accessories?

EBERLE Shaver System C3 and Accessories is manufactured by Eberle GmbH & Co. KG.

What is the FDA product code for EBERLE Shaver System C3 and Accessories?

The FDA product code for EBERLE Shaver System C3 and Accessories is HRX.

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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.