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 Tube Tracheostomy And Tube Cuff
510(k) Number K123699
Device Name FAHL TRACHEOSTOMY TUBES (MULTIPLE)
Applicant
Andreas Fahl Medizintechnik-Vertrieb GmbH
August-Horch-Str. 4a
Koeln,  DE 51149
Applicant Contact CLAUDIA WINTERSCHLADEN
Correspondent
Andreas Fahl Medizintechnik-Vertrieb GmbH
August-Horch-Str. 4a
Koeln,  DE 51149
Correspondent Contact CLAUDIA WINTERSCHLADEN
Regulation Number868.5800
Classification Product Code
JOH  
Subsequent Product Codes
BTO   BTR  
Date Received12/03/2012
Decision Date 08/12/2013
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
-
-