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 Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
510(k) Number K151107
Device Name CoSense ETCO Monitor
Applicant
Capnia, Inc.
3 Twin Dolphin Dr. Suite 160
Redwood City,  CA  04065
Applicant Contact KRISTEN YEN
Correspondent
Capnia, Inc.
3 Twin Dolphin Dr. Suite 160
Redwood City,  CA  04065
Correspondent Contact KRISTEN YEN
Regulation Number868.1430
Classification Product Code
CCJ  
Date Received04/27/2015
Decision Date 07/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-