FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
BMC RF CANNULA
K Number: K972846
·
Decision Jul 17, 1998
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
62
Applicant Total
28
Review Days
350
Basic Information
- Device Name
- BMC RF CANNULA
- K Number
- K972846
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4725
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BAYLIS MEDICAL CO., INC.
- Date Received
- August 1, 1997
- Decision Date
- July 17, 1998
- 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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