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FDA 510(k)

ERBEJET® 2 System

K-Number: K231023 · 2023-06-15

ApplicantErbe Elektromedizin GmbH
Decision Date2023-06-15
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ERBEJET® 2 System is a medical device manufactured by Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2023-06-15 under approval number K231023. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERBEJET® 2 System?

ERBEJET® 2 System is a medical device that received FDA 510(k) clearance on 2023-06-15. It is manufactured by Erbe Elektromedizin GmbH. The 510(k) number is K231023.

When was ERBEJET® 2 System approved by the FDA?

ERBEJET® 2 System received FDA 510(k) clearance on 2023-06-15, under approval number K231023.

What company makes ERBEJET® 2 System?

ERBEJET® 2 System is manufactured by Erbe Elektromedizin GmbH.

What is the FDA product code for ERBEJET® 2 System?

The FDA product code for ERBEJET® 2 System is FQH.

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Official Source

View on FDA Database →

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

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