VO200 – NeurOs Cerebral Oximetry System
FDA 510(k) clearance K182242 · decided 2018-12-26
Clearance details
- K-number
- K182242
- Device name
- VO200 – NeurOs Cerebral Oximetry System
- Applicant
- Mespere Lifesciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-08-20
- Decision date
- 2018-12-26
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- QEM
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waterloo, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.