The following data is part of a premarket notification filed by Synaptic Medical Limited with the FDA for Rithm Id Electrophysiology Catheter.
| Device ID | K133028 |
| 510k Number | K133028 |
| Device Name: | RITHM ID ELECTROPHYSIOLOGY CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | SYNAPTIC MEDICAL LIMITED P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SYNAPTIC MEDICAL LIMITED P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-26 |
| Decision Date | 2014-03-04 |
| Summary: | summary |