The following data is part of a premarket notification filed by Allen Medical Systems, Inc. with the FDA for Allen Infusion Pump Model 3000 And Irrigation 2000.
| Device ID | K921168 |
| 510k Number | K921168 |
| Device Name: | ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 |
| Classification | Infusor, Pressure, For I.v. Bags |
| Applicant | ALLEN MEDICAL SYSTEMS, INC. 5198 RICHMOND RD. Bedford Heights, OH 44146 |
| Contact | Ann Lordeman |
| Correspondent | Ann Lordeman ALLEN MEDICAL SYSTEMS, INC. 5198 RICHMOND RD. Bedford Heights, OH 44146 |
| Product Code | KZD |
| CFR Regulation Number | 880.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-10 |
| Decision Date | 1993-04-21 |