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, st segment with alarm
510(k) Number K012837
Device Name MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
Applicant
DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM,  MA  02492
Applicant Contact JOEL C KENT
Correspondent
DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM,  MA  02492
Correspondent Contact JOEL C KENT
Regulation Number870.1025
Classification Product Code
MLD  
Date Received08/23/2001
Decision Date 09/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-