The following data is part of a premarket notification filed by Ross Medical Technology, Inc with the FDA for Cardiaclinx.
| Device ID | K142352 |
| 510k Number | K142352 |
| Device Name: | CardiacLinx |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | Ross Medical Technology, Inc 82 E. ALLENDALE ROAD, SUITE 8A Saddle River, NJ 07458 |
| Contact | Alexander Chiu |
| Correspondent | Alexander Chiu Ross Medical Technology, Inc 82 E. ALLENDALE ROAD, SUITE 8A Saddle River, NJ 07458 |
| Product Code | DSI |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQK |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-22 |
| Decision Date | 2015-03-12 |
| Summary: | summary |