The following data is part of a premarket notification filed by Healthstats International Pte. Ltd. with the FDA for A-plus Arterial Pulse Waveform Analysis System And Pc Software.
| Device ID | K072593 |
| 510k Number | K072593 |
| Device Name: | A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE |
| 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 | 2007-09-14 |
| Decision Date | 2007-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08885014410036 | K072593 | 000 |