FDA 510(k)
FDA class 1
Substantially Equivalent
🇭🇳 Honduras
CDG GAIT ANALYSES SYSTEM
K Number: K915278
·
Decision Apr 7, 1992
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
10
Applicant Total
2
Review Days
134
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Basic Information
- Device Name
- CDG GAIT ANALYSES SYSTEM
- K Number
- K915278
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.1600
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wrm Computers
- Date Received
- November 25, 1991
- Decision Date
- April 7, 1992
- Product Code
- JFC
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| JFC | System, Pressure Measurement, Intermittent | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JFC), ordered by most recent decision date.
FORCE SENSING ARRAY
FDA 510(k)
FDA Class 1
·Physical Medicine
QA PRESSURE MEASUREMENT SYSTEM
FDA 510(k)
FDA Class 1
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DYNAMIC PRESSURE MONITOR 2000M AND 2000C
FDA 510(k)
FDA Class 1
·Physical Medicine
OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR
FDA 510(k)
FDA Class 1
·Physical Medicine
MECHANICAL SHAPE SENSOR
FDA 510(k)
FDA Class 1
·Physical Medicine
COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Wrm Computers
| K Number | Device Name | ||
|---|---|---|---|
| K915897 | FPL | Apr 7, 1992 | Substantially Equivalent |