EarlyVue VS30— 510(k) K190624
Substantially EquivalentPhilips Medizin Systeme Boeblingen GmbH
FDA 510(k) clearance K190624 for EarlyVue VS30, Substantially Equivalent on 2019-10-27. Applicant: Philips Medizin Systeme Boeblingen GmbH. Device class: 2.
Clearance details
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Product code
- Code DSJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boeblingen, DE
Recent devices under product code DSJ
view allMore clearances from Philips Medizin Systeme Boeblingen GmbH
view all- K252726 — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)
- K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550
- K233440 — Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
- K231671 — IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)
- K230604 — IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)
Recalls naming K190624
K-number listed on FDA's recall record- Z-2654-2023 — EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
- Z-2655-2023 — EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
- Z-1645-2023 — EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190624.
Data sourced from openFDA. This site is unofficial and independent of the FDA.