510(k) K090212 ยท DPS Electrocardiograph
MAC 800 RESTING ECG ANALYSIS SYSTEM
| Applicant | Ge Medical Syst. Information Technologies, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Feb 19, 2009 |
| Received | Jan 28, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090212
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2010 | GE Medical Systems, LLC GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM.
The MAC 800 is a portable EGG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record informatio Terminated |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.