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, Pulmonary Function Data
510(k) Number K992214
Device Name OXYCON PRO
Applicant
ERICH JAEGER B.V.
REGULIERENING 11
NL-3981 LA BUNNIK,  NL NL-3981
Applicant Contact LEO DEN BAKKER
Correspondent
ERICH JAEGER B.V.
REGULIERENING 11
NL-3981 LA BUNNIK,  NL NL-3981
Correspondent Contact LEO DEN BAKKER
Regulation Number868.1880
Classification Product Code
BZC  
Subsequent Product Codes
DPS   MLC   MWI  
Date Received07/01/1999
Decision Date 02/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-