The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Cg-6108 Act-il Continuous Ecg Monitor And Arrythmia Detector.
| Device ID | K101639 |
| 510k Number | K101639 |
| Device Name: | CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 555 ZANG STREET SUITE 100 Lakewood, CO 80228 |
| Contact | Clay Anselmo |
| Correspondent | Clay Anselmo CARD GUARD SCIENTIFIC SURVIVAL, LTD. 555 ZANG STREET SUITE 100 Lakewood, CO 80228 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-10 |
| Decision Date | 2010-06-25 |
| Summary: | summary |