The following data is part of a premarket notification filed by National Cardiac, Inc. with the FDA for Liba3 System.
| Device ID | K182532 |
| 510k Number | K182532 |
| Device Name: | Liba3 System |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | National Cardiac, Inc. 221 W. Crest Street Suite 205 Escondido, CA 92025 |
| Contact | Scott Mallett |
| Correspondent | Don Canal 510k Medical, Inc. 1200 Post Oak Trail Southlake, TX 76092 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-14 |
| Decision Date | 2019-05-15 |
| Summary: | summary |