Data / Medical devices / Australia / ATCOR MEDICAL Pty Ltd
ATCOR MEDICAL Pty Ltd: FDA-registered device maker in SYDNEY New South Wales, Australia, 6 510(k) clearances
ATCOR MEDICAL Pty Ltd is registered with the FDA (registration 9710654) in SYDNEY New South Wales, Australia. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 21, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9710654
- FEI number
- 3003339185
- Address
- 301/55 Lime Street, SYDNEY New South Wales, Australia, 2000
- Owner or operator
- ATCOR MEDICAL Pty Ltd (9048688)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 13, 2007
- Registered through
- 2026
- Brand names listed
- CONNEQT PULSE, SphygmoCor XCEL, SphygmoCor XCEL CP, SphygmoCor XCEL CP + PWV, SphygmoCor XCEL PWA, SphygmoCor XCEL PWA + PWV, SphygmoCor XCEL PWV
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Blood-Pressure | DSK | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 21, 2023 | K221742 | CONNEQT PULSE | DXN | Substantially Equivalent | Atcor Medical | accessdata.fda.gov |
| November 16, 2012 | K122129 | SPHYGMOCOR XCEL | DXN | Substantially Equivalent | Atcor Medical | accessdata.fda.gov |
| April 23, 2008 | K080670 | MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | DSK | Substantially Equivalent | Atcor Medical | accessdata.fda.gov |
| August 31, 2007 | K070795 | SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | DSK | Substantially Equivalent | Atcor Medical Pty, Ltd. | accessdata.fda.gov |
| February 21, 2002 | K012487 | SPHYGMOCOR PX MODEL SCOR-PX | DXN | Substantially Equivalent | Atcor Medical Pty, Ltd. | accessdata.fda.gov |
| May 1, 2001 | K002742 | SPHYGMOCOR MX MODEL SCOR-MX | DSK | Substantially Equivalent | Pwv Medical Pty, Lt. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Computer, Blood-Pressure
- All makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Updated April 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.