Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 K260949
Device Name Disposable Belts for Polysomnography (CNSAC)
Applicant
CNSAC Medshop GmbH
Biebelrieder St. 42
Theilheim,  DE 97288
Applicant Contact Arash Kianian
Correspondent
CNSAC Medshop GmbH
Biebelrieder St. 42
Theilheim,  DE 97288
Correspondent Contact Arash Kianian
Regulation Number868.2375
Classification Product Code
MNR  
Date Received03/23/2026
Decision Date 09/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-