• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name ventilatory effort recorder
510(k) Number K213463
Device Name NightOwl
Ectosense nv
Bosbessenlaan 19 A
Rotselaar,  BE 3110
Applicant Contact Bart Van Pee
Ectosense nv
Bosbessenlaan 19 A
Rotselaar,  BE 3110
Correspondent Contact Bart Van Pee
Regulation Number868.2375
Classification Product Code
Date Received10/27/2021
Decision Date 12/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No