The following data is part of a premarket notification filed by Imed Corp. with the FDA for Imed Gemini 12 Nonvented Y-type Blood/solution Adm.
| Device ID | K894842 |
| 510k Number | K894842 |
| Device Name: | IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM |
| Classification | Set, Administration, Intravascular |
| Applicant | IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
| Contact | Jarboe, Phd |
| Correspondent | Jarboe, Phd 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 | 1989-07-31 |
| Decision Date | 1989-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885403283961 | K894842 | 000 |
| 37613203012660 | K894842 | 000 |
| 37613203019171 | K894842 | 000 |
| 37613203019478 | K894842 | 000 |
| 37613203019676 | K894842 | 000 |
| 50885403225749 | K894842 | 000 |
| 50885403233782 | K894842 | 000 |
| 50885403233997 | K894842 | 000 |
| 50885403235120 | K894842 | 000 |
| 37613203011328 | K894842 | 000 |