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 K913790
Device Name SENSORMEDICS OXYSHUTTLE II(TM)
Applicant
SENSORMEDICS CORP.
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Applicant Contact DAVID M TRUEBLOOD
Correspondent
SENSORMEDICS CORP.
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Correspondent Contact DAVID M TRUEBLOOD
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/23/1991
Decision Date 02/26/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-