510(k) K240148
- Device
- SCIg60 Infusion System
- Applicant
- Emed Technologies Corporation
- 510(k) number
- K240148
- Product code
- PKP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-02-16
- Date received
- 2024-01-19
- Regulation
- 880.5725
- Classification name
- Immunoglobulin G (Igg) Infusion System
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Olena Whalen
- Address
- 1262 Hawks Flight Ct. Suite 200 El Dorado Hills CA US 95762 95762
FDA Registration Numbers#
- 9680306
- 3008132411
- 3010236732
- 1319660
- 3008570882
- 3018229072
- 3024122953
- 3007428065
- 2523167
- 3003927385
Source Documents#
Other 510(k) Records For Product Code PKP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | 2025-12-22 |
| K230883 | VersaPump Infusion System | Emed Technologies Corporation | 2023-11-28 |
| K222087 | SCIg60 Infusion System | Emed Technologies Corporation | 2022-10-13 |
| K173783 | SCIg60 Infusion System | Emed Technologies Corporation | 2018-12-14 |
| K161906 | SCIg60 Infuser | Emed Technologies Corporation | 2016-12-01 |
| K142319 | SCIg60 Infuser, Infuset | Emed Technologies Corporation | 2015-05-14 |