FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRANET-S COLLIMATOR
K Number: K894142
·
Decision Nov 6, 1989
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
22
Applicant Total
169
Review Days
146
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Basic Information
- Device Name
- ULTRANET-S COLLIMATOR
- K Number
- K894142
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1610
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- GE Medical Systems
- Date Received
- June 13, 1989
- Decision Date
- November 6, 1989
- Product Code
- IZW
- 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 |
|---|---|---|---|
| IZW | Collimator, Automatic, Radiographic | FDA class 2 | Radiology |
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