FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TUMBLE FORMS JUNIOR TRISTANDER
K Number: K940238
·
Decision Mar 7, 1994
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
34
Applicant Total
2
Review Days
47
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Basic Information
- Device Name
- TUMBLE FORMS JUNIOR TRISTANDER
- K Number
- K940238
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3750
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Camp Intl., Inc.
- Date Received
- January 19, 1994
- Decision Date
- March 7, 1994
- Product Code
- INW
- 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 |
|---|---|---|---|
| INW | Table, Mechanical | FDA class 1 | Physical Medicine |
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Other Clearances by Camp Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K935998 | ENTERPRISE | Nov 17, 1995 | Substantially Equivalent |