FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO-MAX, MODEL 319
K Number: K002404
·
Decision Aug 30, 2000
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
82
Applicant Total
1
Review Days
23
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Basic Information
- Device Name
- MICRO-MAX, MODEL 319
- K Number
- K002404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tek Marketing, Inc.
- Date Received
- August 7, 2000
- Decision Date
- August 30, 2000
- Product Code
- IXW
- 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 |
|---|---|---|---|
| IXW | Processor, Radiographic-Film, Automatic | FDA class 2 | Radiology |
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