• 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 oximeter
510(k) Number K102270
Device Name ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN
Applicant
ENVITEC-WISMAR GMBH
S65 W35739 PIPER ROAD
EAGLE,  WI  53119
Applicant Contact STEPHEN GORSKI
Correspondent
ENVITEC-WISMAR GMBH
S65 W35739 PIPER ROAD
EAGLE,  WI  53119
Correspondent Contact STEPHEN GORSKI
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/10/2010
Decision Date 02/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-