The following data is part of a premarket notification filed by Healthstats International Pte Ltd with the FDA for Bpro Bt Ambulatory Blood Pressure Monitoring System With Bprosoft Bt Pc Software.
| Device ID | K173028 |
| 510k Number | K173028 |
| Device Name: | BPro BT Ambulatory Blood Pressure Monitoring System With BProSoft BT PC Software |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | HealthSTATS International Pte Ltd 3 Ang Mo Kio Street 62 #08-25/26, Link@Amk Singapore, SG 536199 |
| Contact | Ngak Hwee Chua |
| Correspondent | Stephen Gorski Imagenix, Inc. S65 W35739 Piper Road Eagle, WI 53119 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2018-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08885014410098 | K173028 | 000 |
| 08885014410005 | K173028 | 000 |