Philips IntelliVue GuardianSoftware (Rev. E.0X)— 510(k) K212208
Substantially EquivalentPhilips Medizin Systeme Boeblingen GmbH
FDA 510(k) clearance K212208 for Philips IntelliVue GuardianSoftware (Rev. E.0X), Substantially Equivalent on 2021-09-30. Applicant: Philips Medizin Systeme Boeblingen GmbH. Device class: 2.
Clearance details
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Product code
- Code DXJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boeblingen, DE
Recent devices under product code DXJ
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)
Adverse events under product code DXJ
product code DXJ- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.