The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Model 750e Series Monitor.
Device ID | K051896 |
510k Number | K051896 |
Device Name: | MODEL 750E SERIES MONITOR |
Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
Applicant | CAS MEDICAL SYSTEMS, INC. 44 EAST INDUSTRIAL RD. Branford, CT 06405 |
Contact | Ron Jeffrey |
Correspondent | Ron Jeffrey CAS MEDICAL SYSTEMS, INC. 44 EAST INDUSTRIAL RD. Branford, CT 06405 |
Product Code | MWI |
Subsequent Product Code | BZQ |
Subsequent Product Code | DRT |
Subsequent Product Code | FLL |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-13 |
Decision Date | 2005-12-16 |
Summary: | summary |