The following data is part of a premarket notification filed by Proton Healthcare Ltd. with the FDA for Proton Digital Blood Pressure Monitor, Models Ph168a, Ph168e, Ph168w, Phc888ja, Ph888ha.
| Device ID | K051565 |
| 510k Number | K051565 |
| Device Name: | PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | PROTON HEALTHCARE LTD. 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls PROTON HEALTHCARE LTD. 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-14 |
| Decision Date | 2005-09-12 |