GGZ — Oxyhemoglobin Class II
FDA Device Classification
Classification Details
- Product Code
- GGZ
- Device Class
- Class II
- Regulation Number
- 864.7500
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K200204 | nova biomedical corporation | Stat Profile Prime Plus Analyzer System | April 6, 2020 |
| K180186 | nova biomedical corporation | Stat Profile Prime Plus Analyzer System | August 23, 2018 |