PHILIPS M3001A MULTI MEASUREMENT SERVER— 510(k) K090360
Substantially EquivalentPhilips Medizin Systeme Boblingen GmbH
FDA 510(k) clearance K090360 for PHILIPS M3001A MULTI MEASUREMENT SERVER, Substantially Equivalent on 2009-05-04. Applicant: Philips Medizin Systeme Boblingen GmbH. Device class: 2.
Clearance details
- Applicant
- Philips Medizin Systeme Boblingen GmbH
- Product code
- Code DQA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boeblingen, DE
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- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
- K252448 — AViTA Pulse Oximeter (SP61)
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- K113657 — INTELLIVUE PATIENT MONITOR
- K102958 — PHILIPS AVALON FETAL MONITOR
- K102562 — INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800
Adverse events under product code DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
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.