FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RADKOR BS-10 AND BS-10T
K Number: K891395
·
Decision Apr 3, 1989
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
20
Applicant Total
10
Review Days
20
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Basic Information
- Device Name
- RADKOR BS-10 AND BS-10T
- K Number
- K891395
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1880
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Radkor, Inc.
- Date Received
- March 14, 1989
- Decision Date
- April 3, 1989
- Product Code
- IXY
- 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 |
|---|---|---|---|
| IXY | Holder, Radiographic Cassette, Wall-Mounted | FDA class 1 | Radiology |
Similar 510(k) Clearances
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NTBS-1417, 1436, TBS-1417
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RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER
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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 |
| K883885 | RADKOR, RF-159 | Oct 19, 1988 | Substantially Equivalent |
| K883864 | RADKOR SFR-70 | 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 |