The following data is part of a premarket notification filed by Imed Corp. with the FDA for The Imed Orion Infusion Pump And Administration Sets.
| Device ID | K950419 |
| 510k Number | K950419 |
| Device Name: | THE IMED ORION INFUSION PUMP AND 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 | 1995-01-31 |
| Decision Date | 1995-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885403245419 | K950419 | 000 |
| 37613203019232 | K950419 | 000 |
| 10885403810015 | K950419 | 000 |
| 10885403222054 | K950419 | 000 |