The following data is part of a premarket notification filed by Healthwatch Ltd. with the FDA for Master Caution Device Mcd.
| Device ID | K142476 |
| 510k Number | K142476 |
| Device Name: | Master Caution Device MCD |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | HealthWatch Ltd. 6 Hasadna Street Kfar Saba, IL 44424 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy QSITE 31 HAAVODA STREET Binyamina, IL 30500 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-03 |
| Decision Date | 2015-02-17 |
| Summary: | summary |