FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE
K Number: K881284
·
Decision Jul 21, 1988
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
10
Applicant Total
1
Review Days
118
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Basic Information
- Device Name
- COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE
- K Number
- K881284
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.1600
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Nathaniel Gould Diagnostics, Inc.
- Date Received
- March 25, 1988
- Decision Date
- July 21, 1988
- 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 |
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