The following data is part of a premarket notification filed by Healthstats International Pte. Ltd. with the FDA for Healthstats Bpro Ambulatory Blood Pressure Monitoring System.
| Device ID | K060315 |
| 510k Number | K060315 |
| Device Name: | HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | HEALTHSTATS INTERNATIONAL PTE. LTD. S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Contact | Stephen Gorski |
| Correspondent | Stephen Gorski HEALTHSTATS INTERNATIONAL PTE. LTD. S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-08 |
| Decision Date | 2006-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08885014410104 | K060315 | 000 |
| 08885014410012 | K060315 | 000 |