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 Device, Positive Pressure Breathing, Intermittent
510(k) Number K113549
Device Name COMFORT COUGH
Applicant
Seoil Pacific Corp.
Rm.# 515-516, Ace High-End
Tower 235-2 Guro-Dong
Seoul,  KR 573-901
Applicant Contact Priscilla Chung
Correspondent
Seoil Pacific Corp.
Rm.# 515-516, Ace High-End
Tower 235-2 Guro-Dong
Seoul,  KR 573-901
Correspondent Contact Priscilla Chung
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received12/01/2011
Decision Date 02/21/2013
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
-
-