The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Ivsk09 Calibration Kit An Accessory To Iv7000/7200.
| Device ID | K890786 |
| 510k Number | K890786 |
| Device Name: | IVSK09 CALIBRATION KIT AN ACCESSORY TO IV7000/7200 |
| Classification | Pump, Infusion |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Peggy Walline |
| Correspondent | Peggy Walline VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-15 |
| Decision Date | 1989-07-28 |