FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
K Number: K090608
·
Decision Jun 14, 2010
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
65
Applicant Total
1
Review Days
465
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Basic Information
- Device Name
- MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
- K Number
- K090608
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4725
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Minta Medical Limited
- Date Received
- March 6, 2009
- Decision Date
- June 14, 2010
- Product Code
- GXI
- 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 |
|---|---|---|---|
| GXI | Probe, Radiofrequency Lesion | FDA class 2 | Neurology |
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