OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension; Injector, OptiOne Base System— 510(k) K152361
Substantially EquivalentLiebel-Flarsheim Company, LLC
FDA 510(k) clearance K152361 for OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension; Injector, OptiOne Base System, Substantially Equivalent on 2016-01-14. Applicant: Liebel-Flarsheim Company, LLC. Device class: 2.
Clearance details
- Device name as filed
- OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System
- Applicant
- Liebel-Flarsheim Company, LLC
- Product code
- Code IZQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
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More clearances from Liebel-Flarsheim Company, LLC
view allAdverse events under product code IZQ
product code IZQ- Death
- 7
- Total
- 7
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.