K230883 is an FDA 510(k) clearance for the VersaPump Infusion System. This device is classified as a Immunoglobulin G (igg) Infusion System (Class II - Special Controls, product code PKP).
Submitted by Emed Technologies Corporation (El Dorado Hills, US). The FDA issued a Cleared decision on November 28, 2023, 243 days after receiving the submission on March 30, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725. An Immunoglobulin G (igg) Infusion System Is A Prescription Device Intended For Subcutaneous Delivery Of Immunoglobulin G (igg) In Accordance With The Fda Approved Labeling..
| 510(k) Number | K230883 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2023 |
| Decision Date | November 28, 2023 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PKP - Immunoglobulin G (igg) Infusion System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |
| Definition | An Immunoglobulin G (igg) Infusion System Is A Prescription Device Intended For Subcutaneous Delivery Of Immunoglobulin G (igg) In Accordance With The Fda Approved Labeling. |