The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for 740 Select.
Device ID | K140430 |
510k Number | K140430 |
Device Name: | 740 SELECT |
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 |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-19 |
Decision Date | 2014-06-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
740 SELECT 85832779 4539078 Live/Registered |
CAS Medical Systems, Inc. 2013-01-25 |