The following data is part of a premarket notification filed by Card Guard Scientific Survival Ltd. with the FDA for Cg-5108 Act-3l Continuous Ecg Monitor And Arrhythmia Detector.
| Device ID | K110499 |
| 510k Number | K110499 |
| Device Name: | CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL LTD. 555 ZANG ST SUITE 100 Lakewood, CO 80228 |
| Contact | Clay Anselmo |
| Correspondent | Clay Anselmo CARD GUARD SCIENTIFIC SURVIVAL LTD. 555 ZANG ST 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 | 2011-02-22 |
| Decision Date | 2011-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850725007095 | K110499 | 000 |
| 00850725007019 | K110499 | 000 |
| 00850725007002 | K110499 | 000 |