FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM
K Number: K884723
·
Decision Feb 8, 1989
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
32
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- (DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM
- K Number
- K884723
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.1500
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Greenleaf Medical Systems, Inc.
- Date Received
- November 10, 1988
- Decision Date
- February 8, 1989
- 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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