FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PATIENT RESTRAINT
K Number: K970272
·
Decision Apr 11, 1997
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
133
Applicant Total
4
Review Days
78
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Basic Information
- Device Name
- PATIENT RESTRAINT
- K Number
- K970272
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6760
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fla Orthopedics, Inc.
- Date Received
- January 23, 1997
- Decision Date
- April 11, 1997
- Product Code
- FMQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMQ | Restraint, Protective | FDA class 1 | General Hospital |
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