The following data is part of a premarket notification filed by Caesarea Medical Electronics Ltd. with the FDA for Niki T34 And Bodyguard T34 Syringe Drivers.
| Device ID | K050800 |
| 510k Number | K050800 |
| Device Name: | NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS |
| Classification | Pump, Infusion |
| Applicant | CAESAREA MEDICAL ELECTRONICS LTD. 16 SHACHAM STREET P.O.B. 4294 Caesarea, IL 38900 |
| Contact | Gali Tzury |
| Correspondent | Gali Tzury CAESAREA MEDICAL ELECTRONICS LTD. 16 SHACHAM STREET P.O.B. 4294 Caesarea, IL 38900 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-30 |
| Decision Date | 2005-11-23 |