510(k) K130626 ยท DQK Computer, Diagnostic, Programmable
MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS
| Applicant | Ge Medical Systems Information Technologies, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, May 1, 2013 |
| Received | Mar 8, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130626
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2019 | GE Healthcare, LLC CardioLab/ComboLab Recording Systems Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.