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 Calculator, Predicted Values, Pulmonary Function
510(k) Number K980094
Device Name MODIFICATION TO THE OXYCONALPHA
Applicant
Erich Jaeger B.V.
Regulierening 11
Nl-3981 La Bunnik,  NL NL-3981
Applicant Contact LEO D BAKKER
Correspondent
Erich Jaeger B.V.
Regulierening 11
Nl-3981 La Bunnik,  NL NL-3981
Correspondent Contact LEO D BAKKER
Regulation Number868.1890
Classification Product Code
BTY  
Date Received01/09/1998
Decision Date 07/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-