510(k) K041674 ยท DQA Oximeter
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Jul 19, 2004 |
| Received | Jun 21, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041674
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2008 | Philips Medical Systems M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A, software revision identified as Build 1.1.2.11d, B.02.07. Prescriptive medical device used to aut Terminated |
DQA | None listed |
| Sep 18, 2008 | Philips Medical Systems Philips Telemonitoring System Software (M3811B) used with
Philips Telemonitoring System (M3810B)
Revision: B.02.07
Prescriptive medical device used to automatically collect and transmit medical info Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.