The following data is part of a premarket notification filed by Pwv Medical Pty, Lt. with the FDA for Sphygmocor Mx Model Scor-mx.
| Device ID | K002742 |
| 510k Number | K002742 |
| Device Name: | SPHYGMOCOR MX MODEL SCOR-MX |
| Classification | Computer, Blood-pressure |
| Applicant | PWV MEDICAL PTY, LT. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | Kirsten H Paulson |
| Correspondent | Kirsten H Paulson PWV MEDICAL PTY, LT. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-01 |
| Decision Date | 2001-05-01 |