510(k) K113144 ยท DPS Electrocardiograph
PAGEWRITER TC 20, 30, 50, 70
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Apr 3, 2012 |
| Received | Oct 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113144
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2019 | Philips North America, LLC PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | None listed |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | None listed |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | None listed |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | None listed |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05. 22 to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | None listed |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | None listed |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | None listed |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | None listed |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.