The following data is part of a premarket notification filed by Imed Corp. with the FDA for Primary Admin Set W/univ Sp-man Below/abv Pump Ch.
| Device ID | K931173 |
| 510k Number | K931173 |
| Device Name: | PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-08 |
| Decision Date | 1994-04-15 |