FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)
K Number: K943929
·
Decision May 15, 1995
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
32
Applicant Total
4
Review Days
276
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Basic Information
- Device Name
- DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)
- K Number
- K943929
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.1500
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Greenleaf Medical Systems, Inc.
- Date Received
- August 12, 1994
- Decision Date
- May 15, 1995
- Product Code
- KQX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| KQX | Goniometer, Ac-Powered | FDA class 1 | Orthopedic |
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