510(k) K120855 ยท DQK Computer, Diagnostic, Programmable
INTELLISPACE ECG
| Applicant | Philips Health Care, Thousand Oaks CA, US |
| Decision | Substantially Equivalent, Jun 29, 2012 |
| Received | Mar 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120855
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2014 | Philips Medical Systems, Inc. Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System.
Model No. 860426 Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.