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
50190752187823	K183364	000
10190752187818	K183364	000
10190752191525	K183364	000
10190752188860	K183364	000
10190752191518	K183364	000