The following data is part of a premarket notification filed by Atcor Medical Pty. Ltd with the FDA for Sphygmocor Px Model Scor-px.
| Device ID | K012487 |
| 510k Number | K012487 |
| Device Name: | SPHYGMOCOR PX MODEL SCOR-PX |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ATCOR MEDICAL PTY. LTD 1400 16TH STREET, NW SUITE 400 Washington, DC 20036 |
| Contact | Kirsten Paulson |
| Correspondent | Kirsten Paulson ATCOR MEDICAL PTY. LTD 1400 16TH STREET, NW SUITE 400 Washington, DC 20036 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-02 |
| Decision Date | 2002-02-21 |
| Summary: | summary |