The following data is part of a premarket notification filed by Atcor Medical with the FDA for Modification To Sphygmocor Cardiovascular Management System.
| Device ID | K080670 |
| 510k Number | K080670 |
| Device Name: | MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM |
| Classification | Computer, Blood-pressure |
| Applicant | ATCOR MEDICAL 11/1059-1063 VICTORIA ROAD West Ryde Nsw, AU 2114 |
| Contact | John Abram |
| Correspondent | John Abram ATCOR MEDICAL 11/1059-1063 VICTORIA ROAD West Ryde Nsw, AU 2114 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-10 |
| Decision Date | 2008-04-23 |
| Summary: | summary |