The following data is part of a premarket notification filed by Liebel-flarsheim Company Llc with the FDA for Optione Single-head Contrast Delivery System With Pedestal; With Ceiling Suspension;injector, Optione Base System.
| Device ID | K152361 |
| 510k Number | K152361 |
| Device Name: | OptiOne Single-Head Contrast Delivery System With Pedestal; With Ceiling Suspension;Injector, OptiOne Base System |
| Classification | Injector, Contrast Medium, Automatic |
| Applicant | Liebel-Flarsheim Company LLC 2111 East Galbraith Rd Cincinnati, OH 45237 |
| Contact | Craig Buehler |
| Correspondent | Craig Buehler Liebel-Flarsheim Company LLC 2111 East Galbraith Rd Cincinnati, OH 45237 |
| Product Code | IZQ |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-20 |
| Decision Date | 2016-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10746190004325 | K152361 | 000 |
| 10746190004318 | K152361 | 000 |
| 10746190002758 | K152361 | 000 |