The following data is part of a premarket notification filed by Emed Technologies Corporation with the FDA for Scig60 Infusion System.
| Device ID | K173783 |
| 510k Number | K173783 |
| Device Name: | SCIg60 Infusion System |
| Classification | Immunoglobulin G (igg) Infusion System |
| Applicant | EMED Technologies Corporation 1264 Hawks Flight Ct, Suite 200 El Dorado Hills, CA 95762 |
| Contact | Peter Kollings |
| Correspondent | Peter Kollings EMED Technologies Corporation 1264 Hawks Flight Ct, Suite 200 El Dorado Hills, CA 95762 |
| Product Code | PKP |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-13 |
| Decision Date | 2018-12-14 |