FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
K Number: K071984
·
Decision Jun 27, 2008
Classifications
1
FEI Numbers
63
Registration Numbers
64
Same Product Code
102
Applicant Total
4
Review Days
344
Basic Information
- Device Name
- MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
- K Number
- K071984
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1620
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CMA MICRODIALYSIS AB
- Date Received
- July 19, 2007
- Decision Date
- June 27, 2008
- Product Code
- GWM
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | FDA class 2 | Neurology |
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