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FDA 510(k)

EBERLE Shaver System C3 and Accessories

K-Number: K193608 · 2021-01-15

ApplicantEberle GmbH & Co. KG
Decision Date2021-01-15
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EBERLE Shaver System C3 and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Eberle GmbH & Co. KG. It received FDA 510(k) clearance on 2021-01-15 under 510(k) 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. The listed applicant is Eberle GmbH & Co. KG. The 510(k) number is K193608.

When did EBERLE Shaver System C3 and Accessories receive FDA 510(k) clearance?

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

Who is the listed applicant for EBERLE Shaver System C3 and Accessories?

The FDA 510(k) record lists Eberle GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: HRX)

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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