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 K970769
Device Name COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR
Applicant
ARISTO MEDICAL
P.O. BOX 1637
WAUKESHA,  WI  53187 -1637
Applicant Contact LARRY LEPLEY
Correspondent
ARISTO MEDICAL
P.O. BOX 1637
WAUKESHA,  WI  53187 -1637
Correspondent Contact LARRY LEPLEY
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/03/1997
Decision Date 08/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-