The following data is part of a premarket notification filed by Caesarea Medical Electronics Ltd. with the FDA for Bodyguard Infusion System.
| Device ID | K031749 |
| 510k Number | K031749 |
| Device Name: | BODYGUARD INFUSION SYSTEM |
| Classification | Pump, Infusion |
| Applicant | CAESAREA MEDICAL ELECTRONICS LTD. 16 SHACHAM STREET CAESAREA INDUSTRIAL PARK Caesarea, IL 38900 |
| Contact | Gali Tzury |
| Correspondent | Chris Lavanchy CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-06-05 |
| Decision Date | 2003-08-21 |