Reusable Guides Ranges (PERINE Range, NAIL Range, CON-LEAD Range And LIN-LEAD Range) And STEADY PRO Range

Transducer, Ultrasonic, Diagnostic

Koelis

The following data is part of a premarket notification filed by Koelis with the FDA for Reusable Guides Ranges (perine Range, Nail Range, Con-lead Range And Lin-lead Range) And Steady Pro Range.

Pre-market Notification Details

• Device ID: K171040
• 510k Number: K171040
• Device Name: Reusable Guides Ranges (PERINE Range, NAIL Range, CON-LEAD Range And LIN-LEAD Range) And STEADY PRO Range
• Classification: Transducer, Ultrasonic, Diagnostic
• Applicant: Koelis 16, Chemin Du Vieux Chene Meylan, FR 38240
• Contact: Laetitia Gervais
• Correspondent: Laetitia Gervais; Koelis 16, Chemin Du Vieux Chene Meylan, FR 38240
• Product Code: ITX
• CFR Regulation Number: 892.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-06
• Decision Date: 2017-07-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03665134000202	K171040	000
03665134000301	K171040	000
03665134000318	K171040	000
03665134000158	K171040	000
03665134000325	K171040	000
03665134000738	K171040	000
03665134000745	K171040	000
03665134000783	K171040	000
03665134000806	K171040	000
03665134000110	K171040	000
03665134000172	K171040	000
03665134000141	K171040	000
03665134000134	K171040	000
03665134000189	K171040	000