FDA Product Code
FDA Product Code PKP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5725
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | 2025-12-22 | Traditional | PDF ↗ |
| K240148 | SCIg60 Infusion System | Emed Technologies Corporation | 2024-02-16 | Special | PDF ↗ |
| K230883 | VersaPump Infusion System | Emed Technologies Corporation | 2023-11-28 | Traditional | PDF ↗ |
| K222087 | SCIg60 Infusion System | Emed Technologies Corporation | 2022-10-13 | Traditional | PDF ↗ |
| K173783 | SCIg60 Infusion System | Emed Technologies Corporation | 2018-12-14 | Traditional | PDF ↗ |
| K161906 | SCIg60 Infuser | Emed Technologies Corporation | 2016-12-01 | Traditional | PDF ↗ |
| K142319 | SCIg60 Infuser, Infuset | Emed Technologies Corporation | 2015-05-14 | Traditional | PDF ↗ |
Product code PKP · Class II · General Hospital. Data: openFDA.