FDA Product Code
FDA Product Code FOA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6080
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221901 | EleGARD | Advancedcpr Solutions, LLC | 2022-07-29 | Special | PDF ↗ |
| K191689 | EleGARD Patient Positioning System | Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio | 2020-02-13 | Traditional | PDF ↗ |
| K811397 | ECA | Gillco, Inc. | 1981-07-02 | Traditional | PDF ↗ |
Product code FOA · Class I · General Hospital. Data: openFDA.