AirView

Ventilator, Continuous, Facility Use

RESMED LTD.

The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Airview.

Pre-market Notification Details

• Device ID: K151901
• 510k Number: K151901
• Device Name: AirView
• Classification: Ventilator, Continuous, Facility Use
• Applicant: RESMED LTD. 1 ELIZABETH MACARTHUR DRIVE Bella Vista, AU 2153
• Contact: Jasjit Baveja
• Correspondent: Larissa D'andrea; ResMed Corp 9001 SPECTRUM CENTER BOULEVARD San Diego, CA 92123
• Product Code: CBK
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-07-10
• Decision Date: 2015-11-05
• Summary: summary