K161906 is an FDA 510(k) clearance for the SCIg60 Infuser. 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 December 1, 2016, 142 days after receiving the submission on July 12, 2016.
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 | K161906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2016 |
| Decision Date | December 01, 2016 |
| Days to Decision | 142 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. |