FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
P.R.M. 80
K Number: K810590
·
Decision Apr 10, 1981
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
22
Applicant Total
1
Review Days
37
Basic Information
- Device Name
- P.R.M. 80
- K Number
- K810590
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1610
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- T.E.M. INSTRUMENTS LTD.
- Date Received
- March 4, 1981
- Decision Date
- April 10, 1981
- 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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