FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
OCTOSTOP(R) CHAIR (NEW MODEL
K Number: K935444
·
Decision Sep 2, 1994
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
76
Applicant Total
13
Review Days
294
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OCTOSTOP(R) CHAIR (NEW MODEL
- K Number
- K935444
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Octostop, Inc.
- Date Received
- November 12, 1993
- Decision Date
- September 2, 1994
- 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
FDA 510(k)
FDA Class 2
·Radiology
LEGACY/LEGACY-D TABLE
FDA 510(k)
FDA Class 2
·Radiology
CAP-35B III/CINE 275
FDA 510(k)
FDA Class 2
·Radiology
PHILIPS EASY DIAGNOST
FDA 510(k)
FDA Class 2
·Radiology
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 Octostop, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972766 | PIVOTING COMPENSATING FILTERS FOR THE HEAD | Aug 14, 1997 | Substantially Equivalent |
| K963941 | THE PHARAOH COMPENSATING FILTER | Nov 27, 1996 | Substantially Equivalent |
| K953246 | OCTOROLL | Sep 29, 1995 | Substantially Equivalent |
| K952871 | RIDGES PLUS | Jul 20, 1995 | Substantially Equivalent |
| K942916 | OCTOPAQUE UNIVERSAL | Sep 8, 1994 | Substantially Equivalent |
| K940306 | OCTOSTOP COMPENSATING FILTERS | Sep 6, 1994 | Substantially Equivalent |
| K930124 | VARIANT OF OCTOSTOP AND OCTOPAQUE | Feb 9, 1994 | Substantially Equivalent |
| K930357 | ACCESSORY TO UNIVERSAL OCTOPAQUE | Jul 13, 1993 | Substantially Equivalent |
| K926069 | WRIST TRACTION | Jan 21, 1993 | Substantially Equivalent |
| K913659 | LITTLE PRISM | Oct 14, 1992 | Substantially Equivalent |