Cerebral Oximeter
The Cerebral Oximeter is a non-invasive monitoring device used to measure cerebral tissue oxygen saturation, providing clinicians with information about brain oxygenation during surgical procedures or critical care. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 870.2700 in the Cardiovascular specialty, reviewed by the Neurology panel. The product code is QEM. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QEM
- Device Class
- FDA class 2
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
Oximeter to measure cerebral tissue saturation
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K182242 | VO200 NeurOs Cerebral Oximetry System | Dec 26, 2018 | Substantially Equivalent | Mespere Lifesciences, Inc. |
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.