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 K903089
Device Name BABYLOG 8000 INFANT VENTILATOR
Applicant
Drager, Inc.
101 Technology Dr., P.O. Box
120
Pittsburgh,  PA  15230
Applicant Contact STEFAN FREMBGEN
Correspondent
Drager, Inc.
101 Technology Dr., P.O. Box
120
Pittsburgh,  PA  15230
Correspondent Contact STEFAN FREMBGEN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/13/1990
Decision Date 06/10/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-