FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXPLORER LIVER (PASSIVE TRACKING)
K Number: K101979
·
Decision Feb 9, 2011
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
3
Applicant Total
4
Review Days
210
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Basic Information
- Device Name
- EXPLORER LIVER (PASSIVE TRACKING)
- K Number
- K101979
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pathfinder Therapeutics, Inc.
- Date Received
- July 14, 2010
- Decision Date
- February 9, 2011
- Product Code
- OEW
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| OEW | Tracking, Soft Tissue, Intraoperative | FDA class 2 | Neurology |
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