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 Ventilator, Continuous, Facility Use
510(k) Number K142679
Device Name CARESCAPE R860
Applicant
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, PO Box 7550
Madison,  WI  53707 -7550
Applicant Contact Trishia Dwyer
Correspondent
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, PO Box 7550
Madison,  WI  53707 -7550
Correspondent Contact Trishia Dwyer
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/19/2014
Decision Date 06/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-