FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006
K Number: K052309
·
Decision Sep 27, 2005
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
35
Applicant Total
1
Review Days
34
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Basic Information
- Device Name
- DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006
- K Number
- K052309
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1240
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Saehan Corp.
- Date Received
- August 24, 2005
- Decision Date
- September 27, 2005
- Product Code
- LBB
- 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 |
|---|---|---|---|
| LBB | Dynamometer, Ac-Powered | FDA class 2 | Orthopedic |
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