SmartPerfusion— 510(k) K181966
Substantially EquivalentPhilips Medical Systems Nederlands B.V.
FDA 510(k) clearance K181966 for SmartPerfusion, Substantially Equivalent on 2018-08-17. Applicant: Philips Medical Systems Nederlands B.V.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Nederlands B.V.
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Best Noord-Brabant, NL
Recent devices under product code OWB
view allMore clearances from Philips Medical Systems Nederlands B.V.
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
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 K181966
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 K181966.
Data sourced from openFDA. This site is unofficial and independent of the FDA.