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 Cuff, Tracheal Tube, Inflatable
510(k) Number K152778
Device Name TRACOE Cuff Pressure Monitor
Applicant
TRACOE MEDICAL GMBH
REICHELSHEIMER STR. 1/3
NIEDER-OLM,  DE D-55268
Applicant Contact STEPHAN KOHLER
Correspondent
AJW TECHNOLOGY CONSULTANTS, INC.
Reichelsheimer Str. 1/3
Nieder-Olm,  DE D-55268
Correspondent Contact Eva Schaeffer
Regulation Number868.5750
Classification Product Code
BSK  
Date Received09/25/2015
Decision Date 12/21/2016
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
-
-