TRINITY

System, Imaging, Pulsed Doppler, Ultrasonic

KOELIS

The following data is part of a premarket notification filed by Koelis with the FDA for Trinity.

Pre-market Notification Details

• Device ID: K160357
• 510k Number: K160357
• Device Name: TRINITY
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: KOELIS 5 Avenue Du Grand Sablon La Tronche, FR 38700
• Contact: Laetitia Gervais
• Correspondent: Laetitia Gervais; KOELIS 5 Avenue Du Grand Sablon La Tronche, FR 38700
• Product Code: IYN
• Subsequent Product Code: ITX
• Subsequent Product Code: IYO
• Subsequent Product Code: LLZ
• CFR Regulation Number: 892.1550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-08
• Decision Date: 2016-05-02
• Summary: summary