FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
VO200 NeurOs Cerebral Oximetry System
K Number: K182242
·
Decision Dec 26, 2018
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
0
Applicant Total
2
Review Days
128
Basic Information
- Device Name
- VO200 NeurOs Cerebral Oximetry System
- K Number
- K182242
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mespere LifeSciences Inc.
- Date Received
- August 20, 2018
- Decision Date
- December 26, 2018
- Product Code
- QEM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QEM | Cerebral Oximeter | FDA class 2 | Cardiovascular |
Other Clearances by Mespere LifeSciences Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151776 | Central Venous Pressure System | Aug 12, 2015 | Substantially Equivalent |