510(k) K182242
K182242 is an FDA 510(k) premarket notification submitted by Mespere Lifesciences, Inc. for the device "VO200 NeurOs Cerebral Oximetry System". The FDA issued a decision of Substantially Equivalent on December 26, 2018. The device falls under product code QEM (Cerebral Oximeter), a Class II device regulated under 21 CFR 870.2700. Mespere Lifesciences, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 26, 2018
- Date Received
- August 20, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cerebral Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- NE
- Submission Type
Oximeter to measure cerebral tissue saturation