The following data is part of a premarket notification filed by Caesarea Medical Electronics Ltd. with the FDA for T34l Syringe Driver.
| Device ID | K080954 |
| 510k Number | K080954 |
| Device Name: | T34L SYRINGE DRIVER |
| Classification | Pump, Infusion |
| Applicant | CAESAREA MEDICAL ELECTRONICS LTD. 16 SHACHAM STREET INDUSTRIAL PARK Caesarea, IL 38900 |
| Contact | Eva Partas |
| Correspondent | Eva Partas CAESAREA MEDICAL ELECTRONICS LTD. 16 SHACHAM STREET INDUSTRIAL PARK Caesarea, IL 38900 |
| Product Code | FRN |
| Subsequent Product Code | FPA |
| Subsequent Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-03 |
| Decision Date | 2008-05-16 |