FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COURIER II
K Number: K953514
·
Decision Oct 7, 1995
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
3
Review Days
73
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Basic Information
- Device Name
- COURIER II
- K Number
- K953514
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gammex, Inc.
- Date Received
- July 26, 1995
- Decision Date
- October 7, 1995
- Product Code
- LMD
- 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 |
|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | FDA class 1 | Radiology |
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