FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
D.I.V.A.S.
K Number: K812238
·
Decision Sep 11, 1981
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
198
Applicant Total
20
Review Days
31
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Basic Information
- Device Name
- D.I.V.A.S.
- K Number
- K812238
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Cgr Medical Corp.
- Date Received
- August 11, 1981
- Decision Date
- September 11, 1981
- Product Code
- IZI
- 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 |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | FDA class 2 | Radiology |
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|---|---|---|---|
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| K833223 | SONEL 3000A | May 9, 1984 | Substantially Equivalent |
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| K833846 | PROCESS 100 ST | Dec 16, 1983 | Substantially Equivalent |
| K837412 | SATURNE I LINEAR ACCELERATOR | Jun 28, 1983 | Substantially Equivalent |
| K837465 | ALCYON ROTATIONAL COBALT THERAPY | Jun 28, 1983 | Substantially Equivalent |