The following data is part of a premarket notification filed by Ziehm International, Inc. with the FDA for Ims Miniature Volumetric Infusion Pump.
| Device ID | K830454 |
| 510k Number | K830454 |
| Device Name: | IMS MINIATURE VOLUMETRIC INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | ZIEHM INTERNATIONAL, INC. 906-A COMMERCE RD. Annapolis, MD 21401 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-15 |
| Decision Date | 1983-03-31 |