FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOFTIQUE, MODEL GI 11001
K Number: K013707
·
Decision Feb 1, 2002
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
11
Applicant Total
3
Review Days
85
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Basic Information
- Device Name
- SOFTIQUE, MODEL GI 11001
- K Number
- K013707
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5110
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Global TV Concepts, Ltd.
- Date Received
- November 8, 2001
- Decision Date
- February 1, 2002
- Product Code
- IMC
- 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 |
|---|---|---|---|
| IMC | Bath, Paraffin | FDA class 2 | Physical Medicine |
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