The following data is part of a premarket notification filed by Caesarea Medical Electronics Ltd. with the FDA for Bodyguard Pain Manager Infusion System.
| Device ID | K070235 |
| 510k Number | K070235 |
| Device Name: | BODYGUARD PAIN MANAGER INFUSION SYSTEM |
| Classification | Pump, Infusion |
| Applicant | CAESAREA MEDICAL ELECTRONICS LTD. 16 SHACHAM STREET INDUSTRIAL PARK Caesarea, IL 38900 |
| Contact | Shlomi Dines |
| Correspondent | Shlomi Dines CAESAREA MEDICAL ELECTRONICS LTD. 16 SHACHAM STREET INDUSTRIAL PARK Caesarea, IL 38900 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-25 |
| Decision Date | 2007-05-18 |