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 Ventilator, Continuous, Facility Use
510(k) Number K023289
Device Name OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072
Applicant
Drager Medizintechnik GmbH
3136 Quarry Rd.
Telford,  PA  18969
Applicant Contact JAMES J BRENNAN
Correspondent
Drager Medizintechnik GmbH
3136 Quarry Rd.
Telford,  PA  18969
Correspondent Contact JAMES J BRENNAN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/02/2002
Decision Date 01/15/2003
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
-
-