FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PET-SCOPE II MODEL DIS-1611
K Number: K801166
·
Decision Jun 26, 1980
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
3
Review Days
41
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Basic Information
- Device Name
- PET-SCOPE II MODEL DIS-1611
- K Number
- K801166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Information, Inc.
- Date Received
- May 16, 1980
- Decision Date
- June 26, 1980
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
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