510(k) K050844

750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL by Cas Medical Systems, Inc. — Product Code DQA

K050844 is an FDA 510(k) premarket notification submitted by Cas Medical Systems, Inc. for the device "750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL". The FDA issued a decision of Substantially Equivalent on June 23, 2005. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Cas Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2005
Date Received
April 4, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type