The following data is part of a premarket notification filed by Atcor Medical Pty. Ltd with the FDA for Sphygmocor Cardiovascular Management System.
| Device ID | K070795 |
| 510k Number | K070795 |
| Device Name: | SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM |
| Classification | Computer, Blood-pressure |
| Applicant | ATCOR MEDICAL PTY. LTD 1400 16TH STREET, NW SUITE 400 Washington, DC 20036 |
| Contact | Evan P Phelps |
| Correspondent | Evan P Phelps ATCOR MEDICAL PTY. LTD 1400 16TH STREET, NW SUITE 400 Washington, DC 20036 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-22 |
| Decision Date | 2007-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 19351315000017 | K070795 | 000 |