510(k) K051283

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

K051283 is an FDA 510(k) premarket notification submitted by Cardiopulmonary Corp. for the device "MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE". The FDA issued a decision of Substantially Equivalent on June 23, 2005. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Cardiopulmonary Corp. has at least 8 other 510(k) clearances on record.

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