The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Modification To: Cg-6108 Act-3l Continuous Ecg Monitor And Arrhythmia Detector, Model Fg-00084.
| Device ID | K101703 |
| 510k Number | K101703 |
| Device Name: | MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 555 ZANG STREET SUITE 100 Lakewood, CO 80228 |
| Contact | Clay Aneselmo |
| Correspondent | Clay Aneselmo 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 | 2010-06-17 |
| Decision Date | 2010-07-13 |
| Summary: | summary |