The following data is part of a premarket notification filed by Atcor Medical with the FDA for Sphygmocor Xcel.
| Device ID | K122129 |
| 510k Number | K122129 |
| Device Name: | SPHYGMOCOR XCEL |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-18 |
| Decision Date | 2012-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 19351315000031 | K122129 | 000 |