510(k) K190624 ยท DSJ Alarm, Blood-Pressure
EarlyVue VS30
| Applicant | Philips Medizin Systeme Boeblingen GmbH, Boeblingen, DE |
| Decision | Substantially Equivalent, Oct 27, 2019 |
| Received | Mar 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190624
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2023 | Philips North America Llc EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380 Open, Classified |
DSJ | None listed |
| Sep 29, 2023 | Philips North America Llc EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359 Open, Classified |
DSJ | None listed |
| May 26, 2023 | Philips North America Llc EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01
Product Number: 863380 Open, Classified |
DSJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.