ATCOR MEDICAL Pty Ltd
Naperville, IL, US
ATCOR MEDICAL Pty Ltd appears in FDA device records in Naperville, IL. FDA records list 5 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for ATCOR MEDICAL Pty Ltd between 2002 and 2023. The busiest year on record is 2002, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2012 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221742 | CONNEQT PULSE | DXN | Substantially Equivalent | |
| K122129 | SPHYGMOCOR XCEL | DXN | Substantially Equivalent | |
| K080670 | MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | DSK | Substantially Equivalent | |
| K070795 | SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | DSK | Substantially Equivalent | |
| K012487 | SPHYGMOCOR PX MODEL SCOR-PX | DXN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9710654 | 3003339185 | ATCOR MEDICAL Pty Ltd | 301/55 Lime Street, SYDNEY New South Wales 2000 AU | 2026 | |
| 3006791924 | 3006791924 | AtCor Medical Inc. | 184 Shuman Blvd, Suite 515, Naperville, IL 60563 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain