FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WILCOR-XR RP MEDICAL FILM
K Number: K834613
·
Decision Mar 5, 1984
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
33
Applicant Total
5
Review Days
76
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Basic Information
- Device Name
- WILCOR-XR RP MEDICAL FILM
- K Number
- K834613
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1840
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Cea America Corp.
- Date Received
- December 20, 1983
- Decision Date
- March 5, 1984
- Product Code
- IWZ
- 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 |
|---|---|---|---|
| IWZ | Film, Radiographic | FDA class 1 | Radiology |
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Other Clearances by Cea America Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K942525 | MEDICOUNT DEKA HEMATOLOGY ANALYZER | Jun 5, 1996 | Substantially Equivalent |
| K834614 | WILCOR-XR RP-L MEDICAL FILM | Mar 5, 1984 | Substantially Equivalent |
| K834612 | WILCOR-XR RP-OG MEDICAL FILM | Feb 27, 1984 | Substantially Equivalent |
| K834611 | SINGUL-XR RP NON SCREEN MED. FILM | Feb 21, 1984 | Substantially Equivalent |