The following data is part of a premarket notification filed by Caesarea Medical Electronics Ltd. with the FDA for Modification To Bodyguard Infusion Pump System.
| Device ID | K060479 |
| 510k Number | K060479 |
| Device Name: | MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM |
| 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 | 2006-02-23 |
| Decision Date | 2006-05-12 |
| Summary: | summary |