QEM — Cerebral Oximeter Class II
FDA product code QEM covers "Cerebral Oximeter", a Class II medical device regulated under 21 CFR 870.2700. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QEM
- Device Class
- Class II
- Regulation Number
- 870.2700
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Oximeter to measure cerebral tissue saturation
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K182242 | mespere lifesciences | VO200 NeurOs Cerebral Oximetry System | December 26, 2018 |