510(k) K231023

ERBEJET® 2 System by Erbe Elektromedizin GmbH — Product Code FQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2023
Date Received
April 11, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lavage, Jet
Device Class
Class II
Regulation Number
880.5475
Review Panel
HO
Submission Type