APNEALINK

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.

Pre-market Notification Details

• Device ID: K070263
• 510k Number: K070263
• Device Name: APNEALINK
• Classification: Ventilatory Effort Recorder
• Applicant: RESMED GERMANY INC. 14040 DANIELSON ST. Poway, CA 92064 -6857
• Contact: David D'cruz
• Correspondent: David D'cruz; RESMED GERMANY INC. 14040 DANIELSON ST. Poway, CA 92064 -6857
• Product Code: MNR
• CFR Regulation Number: 868.2375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-01-26
• Decision Date: 2007-06-15
• Summary: summary