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FDA 510(k)

ERBE ERBEJET 2 SYSTEM

K-Number: K072404 · 2007-10-31

ApplicantErbe USA, Inc.
Decision Date2007-10-31
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ERBE ERBEJET 2 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Erbe USA, Inc.. It received FDA 510(k) clearance on 2007-10-31 under 510(k) number K072404. 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 ERBE ERBEJET 2 SYSTEM?

ERBE ERBEJET 2 SYSTEM is a medical device that received FDA 510(k) clearance on 2007-10-31. The listed applicant is Erbe USA, Inc.. The 510(k) number is K072404.

When did ERBE ERBEJET 2 SYSTEM receive FDA 510(k) clearance?

ERBE ERBEJET 2 SYSTEM received FDA 510(k) clearance on 2007-10-31, under 510(k) number K072404.

Who is the listed applicant for ERBE ERBEJET 2 SYSTEM?

The FDA 510(k) record lists Erbe USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERBE ERBEJET 2 SYSTEM?

The FDA product code for ERBE 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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