510(k) K051283

MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE by Cardiopulmonary Corp. — Product Code MSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2005
Date Received
May 17, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Network And Communication, Physiological Monitors
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type