ApneaLink Air

Ventilatory Effort Recorder

RESMED GERMANY INC.

The following data is part of a premarket notification filed by Resmed Germany Inc. with the FDA for Apnealink Air.

Pre-market Notification Details

• Device ID: K143272
• 510k Number: K143272
• Device Name: ApneaLink Air
• Classification: Ventilatory Effort Recorder
• Applicant: RESMED GERMANY INC. FRAUNHOFERSTR. 16 Martinsried, DE 82152
• Contact: Sandra Grunwald
• Correspondent: Sandra Grunwald; RESMED GERMANY INC. FRAUNHOFERSTR. 16 Martinsried, DE 82152
• Product Code: MNR
• CFR Regulation Number: 868.2375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-11-14
• Decision Date: 2015-04-30
• Summary: summary