510(k) K033048

CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS by Cas Medical Systems, Inc. — Product Code MHX

K033048 is an FDA 510(k) premarket notification submitted by Cas Medical Systems, Inc. for the device "CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS". The FDA issued a decision of Substantially Equivalent on June 1, 2004. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Cas Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2004
Date Received
September 29, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type