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 Oximeter
510(k) Number K103584
Device Name ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS
Applicant
SHENZHEN ENVISEN INDUSTRY CO. LIMITED
S65 W35739 PIPER ROAD
EAGLE,  WI  53119
Applicant Contact STEPHEN H GORSKI
Correspondent
SHENZHEN ENVISEN INDUSTRY CO. LIMITED
S65 W35739 PIPER ROAD
EAGLE,  WI  53119
Correspondent Contact STEPHEN H GORSKI
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/07/2010
Decision Date 06/10/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-