FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PATIENT RESTRAINT SYSTEM
K Number: K771659
·
Decision Sep 30, 1977
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
133
Applicant Total
5
Review Days
31
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Basic Information
- Device Name
- PATIENT RESTRAINT SYSTEM
- K Number
- K771659
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6760
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Mtd, Inc.
- Date Received
- August 30, 1977
- Decision Date
- September 30, 1977
- Product Code
- FMQ
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| FMQ | Restraint, Protective | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMQ), ordered by most recent decision date.
PROTECTIVE RESTRAINT
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STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
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CENTURION PROTECTIVE RESTRAINT, SCR SERIES
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COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
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INFANT LIMB HOLDER, MODELS 306080 & 306081
FDA 510(k)
FDA Class 1
·General Hospital
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Mtd, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063439 | MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS | Jan 22, 2007 | Substantially Equivalent |
| K833559 | ARMBOARD | Jan 3, 1984 | Substantially Equivalent |
| K791374 | THE MTD VARA SET CASETTE HOLDER | Sep 7, 1979 | Substantially Equivalent |
| K772321 | ARTHROSTRESS | Jan 3, 1978 | Substantially Equivalent |