510(k) K993383 ยท DSI Detector And Alarm, Arrhythmia
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B
| Applicant | Hewlett-Packard GmbH, Boeblingen, DE |
| Decision | Substantially Equivalent, Feb 3, 2000 |
| Received | Oct 8, 1999 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K993383
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2025 | Philips North America Llc Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Open, Classified |
CCK | None listed |
| Jun 8, 2020 | Philips North America, LLC Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036) Terminated |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.