FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
NEUROTHERM RF CANNULA
K Number: K994344
·
Decision Mar 21, 2000
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
65
Applicant Total
19
Review Days
90
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Basic Information
- Device Name
- NEUROTHERM RF CANNULA
- K Number
- K994344
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4725
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rocket Medical Plc
- Date Received
- December 22, 1999
- Decision Date
- March 21, 2000
- 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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