FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLINICOMP R.C.I.
K Number: K842540
·
Decision Aug 8, 1984
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
31
Applicant Total
3
Review Days
37
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Basic Information
- Device Name
- CLINICOMP R.C.I.
- K Number
- K842540
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1360
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Clinicomp, Inc.
- Date Received
- July 2, 1984
- Decision Date
- August 8, 1984
- Product Code
- KPT
- 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 |
|---|---|---|---|
| KPT | Calibrator, Dose, Radionuclide | FDA class 2 | Radiology |
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