The following data is part of a premarket notification filed by Intelesens Limited with the FDA for Zensor System.
| Device ID | K151027 |
| 510k Number | K151027 |
| Device Name: | Zensor System |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | INTELESENS LIMITED 17 HERON ROAD Belfast, GB Bt3 9le |
| Contact | Patricia Pepper |
| Correspondent | Paul Dryden PROMEDIC, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 -2958 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-17 |
| Decision Date | 2015-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060484630089 | K151027 | 000 |
| 05060484630051 | K151027 | 000 |
| 05060484630044 | K151027 | 000 |
| 15060484630003 | K151027 | 000 |