FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM
K Number: K944040
·
Decision Jul 21, 1995
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
4
Review Days
337
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Basic Information
- Device Name
- PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM
- K Number
- K944040
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- S & S X-Ray Products, Inc.
- Date Received
- August 18, 1994
- Decision Date
- July 21, 1995
- Product Code
- IYE
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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