CLEARSCAN

Transducer, Ultrasonic, Diagnostic

ESI, INC.

The following data is part of a premarket notification filed by Esi, Inc. with the FDA for Clearscan.

Pre-market Notification Details

• Device ID: K080119
• 510k Number: K080119
• Device Name: CLEARSCAN
• Classification: Transducer, Ultrasonic, Diagnostic
• Applicant: ESI, INC. 377 ROUTE 17 S Hasbrouck Heights, NJ 07604
• Contact: George Myers
• Correspondent: George Myers; ESI, INC. 377 ROUTE 17 S Hasbrouck Heights, NJ 07604
• Product Code: ITX
• CFR Regulation Number: 892.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-01-17
• Decision Date: 2008-02-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B360CS2001	K080119	000