FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RADKOR SFR-70
K Number: K883864
·
Decision Oct 19, 1988
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
39
Applicant Total
10
Review Days
36
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Basic Information
- Device Name
- RADKOR SFR-70
- K Number
- K883864
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Radkor, Inc.
- Date Received
- September 13, 1988
- Decision Date
- October 19, 1988
- Product Code
- IYB
- 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 |
|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | FDA class 1 | Radiology |
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Other Clearances by Radkor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895969 | RADKOR DXG-650R | Nov 13, 1989 | Substantially Equivalent |
| K892196 | RADKOR TS10-B | Apr 26, 1989 | Substantially Equivalent |
| K891395 | RADKOR BS-10 AND BS-10T | Apr 3, 1989 | Substantially Equivalent |
| K883885 | RADKOR, RF-159 | Oct 19, 1988 | Substantially Equivalent |
| K881701 | RADKOR SFC-21 | Sep 8, 1988 | Substantially Equivalent |
| K883081 | RADKOR, XG-515 | Sep 2, 1988 | Substantially Equivalent |
| K881696 | RADKOR XG-325 | Sep 2, 1988 | Substantially Equivalent |
| K881700 | RADKOR KOB-84 | Sep 2, 1988 | Substantially Equivalent |
| K882563 | RADKOR, CST-18 | Jul 8, 1988 | Substantially Equivalent |