PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50— 510(k) K111083
Substantially EquivalentPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN
FDA 510(k) clearance K111083 for PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50, Substantially Equivalent on 2011-08-17. Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. Device class: 2.
Clearance details
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Product code
- Code HGM
- Device class
- Class 2
- Regulation
- 21 CFR 884.2740
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Boeblingen, Baden-Wuerttemberg, DE
Recent devices under product code HGM
view allMore clearances from Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
view all- K141015 — INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT
- K132320 — INTELLIVUE CL RESPIRATION POD
- K131872 — INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
- K131829 — INTELLIVUE PATIENT MONITOR
- K130849 — INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450
Adverse events under product code HGM
product code HGM- Death
- 35
- Malfunction
- 478
- Total
- 513
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 →
Recalls naming K111083
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111083.
Data sourced from openFDA. This site is unofficial and independent of the FDA.