The following data is part of a premarket notification filed by Mfs - Medical Flow Systems Ltd with the FDA for Multibolus Ii Disposable Pain Management System.
| Device ID | K131247 |
| 510k Number | K131247 |
| Device Name: | MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | MFS - MEDICAL FLOW SYSTEMS LTD ELT BUILDING, DORA INDUSTRIAL ZONE, SHLOMI 22832, ISRAL Shlomi, IL 22832 |
| Contact | Ofer Shay |
| Correspondent | Ofer Shay MFS - MEDICAL FLOW SYSTEMS LTD ELT BUILDING, DORA INDUSTRIAL ZONE, SHLOMI 22832, ISRAL Shlomi, IL 22832 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-01 |
| Decision Date | 2013-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05707480155835 | K131247 | 000 |
| 05707480155798 | K131247 | 000 |
| 05707480155774 | K131247 | 000 |
| 05707480155750 | K131247 | 000 |
| 05707480155712 | K131247 | 000 |