FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KOMET XK-95 PERFORATOR MOTOR (MI-102)
K Number: K991625
·
Decision Jul 30, 1999
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
26
Applicant Total
3
Review Days
80
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Basic Information
- Device Name
- KOMET XK-95 PERFORATOR MOTOR (MI-102)
- K Number
- K991625
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4370
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Komet Medical
- Date Received
- May 11, 1999
- Decision Date
- July 30, 1999
- Product Code
- HBB
- 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 |
|---|---|---|---|
| HBB | Motor, Drill, Pneumatic | FDA class 2 | Neurology |
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