FDA 510(k)
Substantially Equivalent
🇺🇸 United States
OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM
K Number: K837378
·
Decision May 18, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
6
Review Days
62
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Basic Information
- Device Name
- OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM
- K Number
- K837378
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Omnimedical
- Date Received
- March 17, 1983
- Decision Date
- May 18, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
Other Clearances by Omnimedical
| K Number | Device Name | ||
|---|---|---|---|
| K820180 | CALCULI FILTER CUP | Feb 5, 1982 | Substantially Equivalent |
| K812393 | 4001 CT SCANNER | Oct 13, 1981 | Substantially Equivalent |
| K812400 | OMNIMEDICAL QUAD I | Oct 2, 1981 | Substantially Equivalent |
| K802206 | OMNI SCANNER CT 6000 | Oct 23, 1980 | Substantially Equivalent |
| K790673 | OMNIMEDICAL AUTOMATIC 1001 | May 4, 1979 | Substantially Equivalent |