FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANIMATOR
K Number: K770417
·
Decision Apr 15, 1977
Classifications
1
FEI Numbers
340
Registration Numbers
340
Same Product Code
13
Applicant Total
1
Review Days
42
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Basic Information
- Device Name
- ANIMATOR
- K Number
- K770417
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3825
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Kdk Medical Products
- Date Received
- March 4, 1977
- Decision Date
- April 15, 1977
- Product Code
- ITJ
- 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 |
|---|---|---|---|
| ITJ | Walker, Mechanical | FDA class 1 | Physical Medicine |
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