The following data is part of a premarket notification filed by Imed Corp. with the FDA for The Imed Ambulatory Infusion Pump, Administration Sets.
| Device ID | K953896 |
| 510k Number | K953896 |
| Device Name: | THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS |
| Classification | Pump, Infusion |
| Applicant | IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
| Contact | Ahmad Sajadi |
| Correspondent | Ahmad Sajadi IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-17 |
| Decision Date | 1996-03-20 |
| Summary: | summary |