FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDRADJUST IV UROLOGICAL TABLE
K Number: K943581
·
Decision Jan 4, 1995
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
76
Applicant Total
27
Review Days
166
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Basic Information
- Device Name
- HYDRADJUST IV UROLOGICAL TABLE
- K Number
- K943581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mallinckrodt Group, Inc.
- Date Received
- July 22, 1994
- Decision Date
- January 4, 1995
- Product Code
- IXR
- 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 |
|---|---|---|---|
| IXR | Table, Radiographic, Tilting | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IXR), ordered by most recent decision date.
VISION R/F TILTING TABLE
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LEGACY/LEGACY-D TABLE
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PHILIPS EASY DIAGNOST
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ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
FDA 510(k)
FDA Class 2
·Radiology
FLUOROVIEW SERIES FLUOROSCOPIC TABLES
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Mallinckrodt Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945053 | LF CT HIG PRESSURE CATHETERS | May 19, 1995 | Substantially Equivalent |
| K945140 | URO-FLO | Mar 8, 1995 | Substantially Equivalent |
| K943122 | SURGICAL DRAPES | Sep 7, 1994 | Substantially Equivalent |
| K934664 | HYDRAGOWN | May 24, 1994 | Substantially Equivalent |
| K920742 | HYDRAJUST IV UROLOGICAL TABLE | Apr 27, 1992 | Substantially Equivalent |
| K912944 | CT 8000 DIGITAL INJECTION SYSTEM | Feb 4, 1992 | Substantially Equivalent |
| K913264 | HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE | Nov 1, 1991 | Substantially Equivalent |
| K905789 | FRANKLIN 9000 WALL STAND | May 20, 1991 | Substantially Equivalent |
| K904147 | HUGH YOUNG II UROLOGICAL X-RAY SYSTEM | Dec 13, 1990 | Substantially Equivalent |
| K904145 | HYDRA VISION UROLOGICAL X-RAY SYSTEM | Dec 13, 1990 | Substantially Equivalent |