FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
105MM SPOT FILM CAMERA
K Number: K802132
·
Decision Oct 23, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
11
Applicant Total
2
Review Days
50
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Basic Information
- Device Name
- 105MM SPOT FILM CAMERA
- K Number
- K802132
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1620
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Instrumentation Camera, Inc.
- Date Received
- September 3, 1980
- Decision Date
- October 23, 1980
- Product Code
- IZJ
- 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 |
|---|---|---|---|
| IZJ | Camera, X-Ray, Fluorographic, Cine Or Spot | FDA class 2 | Radiology |
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Other Clearances by Instrumentation Camera, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K810716 | X-RAY IMAGE INTENSIFIER PRODUCTS | Apr 23, 1981 | Substantially Equivalent |