FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)
K Number: K963453
·
Decision Nov 15, 1996
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
133
Applicant Total
8
Review Days
73
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)
- K Number
- K963453
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6760
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Contour Fabricators, Inc.
- Date Received
- September 3, 1996
- Decision Date
- November 15, 1996
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMQ), ordered by most recent decision date.
PROTECTIVE RESTRAINT
FDA 510(k)
FDA Class 1
·General Hospital
STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
FDA 510(k)
FDA Class 1
·General Hospital
CENTURION PROTECTIVE RESTRAINT, SCR SERIES
FDA 510(k)
FDA Class 1
·General Hospital
COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
FDA 510(k)
FDA Class 1
·General Hospital
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 Contour Fabricators, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090773 | CFI ULTRASOUND PROBE DRAPE | Sep 18, 2009 | Substantially Equivalent |
| K970900 | INSTRUMENT HOLDER | May 22, 1997 | Substantially Equivalent |
| K971040 | CABLE HOLDER, SUCTION TUBE HOLDER | Apr 16, 1997 | Substantially Equivalent |
| K970185 | STERILE DISPOSABLE EQUIPMENT MAGNET COVER | Apr 10, 1997 | Substantially Equivalent |
| K964141 | GE STERILE DISPOSABLE EQUIPMENT COIL COVER | Jan 30, 1997 | Substantially Equivalent |
| K820692 | BANDBAG, WRAP, STERILE | May 3, 1982 | Substantially Equivalent |
| K782155 | GENERAL EQUIPMENT COVER | Jan 17, 1979 | Substantially Equivalent |