510(k) K222087
K222087 is an FDA 510(k) premarket notification submitted by Emed Technologies Corporation for the device "SCIg60 Infusion System". The FDA issued a decision of Substantially Equivalent on October 13, 2022. The device falls under product code PKP (Immunoglobulin G (Igg) Infusion System), a Class II device regulated under 21 CFR 880.5725. Emed Technologies Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2022
- Date Received
- July 15, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoglobulin G (Igg) Infusion System
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type
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.