The following data is part of a premarket notification filed by I-flow Corp. with the FDA for Iv Bag Pump.
| Device ID | K940657 |
| 510k Number | K940657 |
| Device Name: | IV BAG PUMP |
| Classification | Set, Administration, Intravascular |
| Applicant | I-FLOW CORP. 2532 WHITE RD. Irvine, CA 92714 |
| Contact | Robert J Bard, Ph.d |
| Correspondent | Robert J Bard, Ph.d I-FLOW CORP. 2532 WHITE RD. Irvine, CA 92714 |
| Product Code | FPA |
| Subsequent Product Code | KZD |
| Subsequent Product Code | MEB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-15 |
| Decision Date | 1995-02-03 |