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510(k) K231666

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) by Fujifilm Healthcare Americas Corporation — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2023
Date Received
June 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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