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 K001842
Device Name ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100
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 Received06/19/2000
Decision Date 09/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-