FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MACHNET CAROTIDS COIL ARRAY ASSEMBLY
K Number: K012491
·
Decision Oct 24, 2001
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
3
Review Days
82
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Basic Information
- Device Name
- MACHNET CAROTIDS COIL ARRAY ASSEMBLY
- K Number
- K012491
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Machnet BV
- Date Received
- August 3, 2001
- Decision Date
- October 24, 2001
- Product Code
- MOS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | FDA class 2 | Radiology |
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