The following data is part of a premarket notification filed by Graseby Medical Ltd. with the FDA for 3100 Infusion Pump.
| Device ID | K912192 |
| 510k Number | K912192 |
| Device Name: | 3100 INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | GRASEBY MEDICAL LTD. COLONIAL WAY Watford, Herts., GB Wd24 4lg |
| Contact | Derlien |
| Correspondent | Derlien GRASEBY MEDICAL LTD. COLONIAL WAY Watford, Herts., GB Wd24 4lg |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-17 |
| Decision Date | 1992-02-14 |