CLEAR GUIDE ONE

System, Imaging, Pulsed Echo, Ultrasonic

CLEAR GUIDE MEDICAL

The following data is part of a premarket notification filed by Clear Guide Medical with the FDA for Clear Guide One.

Pre-market Notification Details

• Device ID: K141806
• 510k Number: K141806
• Device Name: CLEAR GUIDE ONE
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: CLEAR GUIDE MEDICAL 40 WARRENTON ROAD Baltimore, MD 21210
• Contact: Jack Kent
• Correspondent: Jack Kent; CLEAR GUIDE MEDICAL 40 WARRENTON ROAD Baltimore, MD 21210
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-07-03
• Decision Date: 2014-09-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B201CGONE1	K141806	000
B201CGOH1	K141806	000
B201CGOHM0	K141806	000
B201CGCORE170	K141806	000