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 K971628
Device Name SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)
Applicant
SOMANETICS CORP.
1653 EAST MAPLE RD.
TROY,  MI  48083 -4208
Applicant Contact RONALD A WIDMAN
Correspondent
SOMANETICS CORP.
1653 EAST MAPLE RD.
TROY,  MI  48083 -4208
Correspondent Contact RONALD A WIDMAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/02/1997
Decision Date 10/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-