The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Neoguard Ecg Electrodes.
| Device ID | K861364 |
| 510k Number | K861364 |
| Device Name: | NEOGUARD ECG ELECTRODES |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CAS MEDICAL SYSTEMS, INC. 29 BUSINESS PARK DR. Branford, CT 06405 |
| Contact | Joel N Helfer |
| Correspondent | Joel N Helfer CAS MEDICAL SYSTEMS, INC. 29 BUSINESS PARK DR. Branford, CT 06405 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-11 |
| Decision Date | 1986-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813880023126 | K861364 | 000 |
| 00813880023119 | K861364 | 000 |
| 00813880023102 | K861364 | 000 |
| 00813880022174 | K861364 | 000 |