NightOwl

Ventilatory Effort Recorder

Ectosense Nv

The following data is part of a premarket notification filed by Ectosense Nv with the FDA for Nightowl.

Pre-market Notification Details

• Device ID: K191031
• 510k Number: K191031
• Device Name: NightOwl
• Classification: Ventilatory Effort Recorder
• Applicant: Ectosense Nv Bosbessenlaan 19A Rotselaar, BE 3110
• Contact: Bart Van Pee
• Correspondent: Bart Van Pee; Ectosense Nv Bosbessenlaan 19A Rotselaar, BE 3110
• Product Code: MNR
• CFR Regulation Number: 868.2375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-04-18
• Decision Date: 2020-03-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05430001742039	K191031	000
05430001742022	K191031	000