The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Cg-6108 Act-3l Continuous Ecg Monitor & Arrhythmia Detector.
| Device ID | K081257 |
| 510k Number | K081257 |
| Device Name: | CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST., SCIENCE PARK Rehovot, IL 76100 |
| Contact | Alex Gonorovsky |
| Correspondent | Alex Gonorovsky CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST., SCIENCE PARK Rehovot, IL 76100 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-02 |
| Decision Date | 2008-05-29 |
| Summary: | summary |