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 System, Network And Communication, Physiological Monitors
510(k) Number K051283
Device Name MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
Applicant
Cardiopulmonary Corp.
200 Cascade Blvd.
Milford,  CT  06460
Applicant Contact JORDAN SCHRECK
Correspondent
Cardiopulmonary Corp.
200 Cascade Blvd.
Milford,  CT  06460
Correspondent Contact JORDAN SCHRECK
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Code
MOD  
Date Received05/17/2005
Decision Date 06/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-