Bellavista

Ventilator, Continuous, Facility Use

Imtmedical AG

The following data is part of a premarket notification filed by Imtmedical Ag with the FDA for Bellavista.

Pre-market Notification Details

• Device ID: K183364
• 510k Number: K183364
• Device Name: Bellavista
• Classification: Ventilator, Continuous, Facility Use
• Applicant: Imtmedical AG Gewerbestrasse 8 Buchs Sg, CH 9470
• Contact: Beat Keller
• Correspondent: Colleen Watson; Vyaire Medical 26125 N. Riverwoods Blvd. Mettawa, IL 60045
• Product Code: CBK
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-12-04
• Decision Date: 2019-09-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07640149388992	K183364	000
07640149380767	K183364	000
10190752188921	K183364	000
10190752188853	K183364	000