The following data is part of a premarket notification filed by Imed Corp. with the FDA for Imed 4100 And 4200 Disposable Infusion Devices Mod.
| Device ID | K913658 |
| 510k Number | K913658 |
| Device Name: | IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
| Contact | Ralph H Jarboe |
| Correspondent | Ralph H Jarboe IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-29 |
| Decision Date | 1992-03-26 |