FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEARPOINT SYSTEM
K Number: K100836
·
Decision Jun 16, 2010
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
4
Review Days
84
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Basic Information
- Device Name
- CLEARPOINT SYSTEM
- K Number
- K100836
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgivision, Inc.
- Date Received
- March 24, 2010
- Decision Date
- June 16, 2010
- Product Code
- ORR
- Advisory Committee
- Neurology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| ORR | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri | FDA class 2 | Neurology |
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