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 Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K000882
Device Name DATEX-OHMEDA CS/3 TELEMETRY SYSTEM
Applicant
DATEX-OHMEDA
THREE HIGHWOOD DR.
TEWKSBURY,  MA  01876
Applicant Contact JOEL KENT
Correspondent
DATEX-OHMEDA
THREE HIGHWOOD DR.
TEWKSBURY,  MA  01876
Correspondent Contact JOEL KENT
Regulation Number870.1025
Classification Product Code
MHX  
Date Received03/20/2000
Decision Date 06/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-