FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRAUMA TABLE
K Number: K853535
·
Decision Sep 11, 1985
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
17
Applicant Total
20
Review Days
19
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Basic Information
- Device Name
- TRAUMA TABLE
- K Number
- K853535
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Xre Corp.
- Date Received
- August 23, 1985
- Decision Date
- September 11, 1985
- Product Code
- GDC
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GDC | Table, Operating-Room, Electrical | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Xre Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K973744 | UNICATH SP BI-PLANE (MODEL M269 & M289) | Dec 29, 1997 | Substantially Equivalent |
| K961193 | FULL FRAME ZOOM SYSTEM | Jun 17, 1996 | Substantially Equivalent |
| K960998 | XRE COLLIMATOR | Apr 3, 1996 | Substantially Equivalent |
| K945449 | UNICATH LLU ANGIOGRAPHIC SYSTEM | Feb 27, 1995 | Substantially Equivalent |
| K936002 | CINEMAC QAS | Sep 9, 1994 | Substantially Equivalent |
| K933460 | DVFX, MODEL M256 | Apr 7, 1994 | Substantially Equivalent |
| K924828 | BI-N | Dec 17, 1992 | Substantially Equivalent |
| K923654 | POLY DIAGNOST CDX | Nov 20, 1992 | Substantially Equivalent |
| K913685 | UNICATH EP. | Nov 7, 1991 | Substantially Equivalent |
| K912416 | ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM | Aug 28, 1991 | Substantially Equivalent |