FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POSEY SITTER
K Number: K920206
·
Decision May 14, 1992
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
30
Applicant Total
13
Review Days
119
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
- POSEY SITTER
- K Number
- K920206
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.2400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- J. T. Posey Co.
- Date Received
- January 16, 1992
- Decision Date
- May 14, 1992
- Product Code
- KMI
- 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 |
|---|---|---|---|
| KMI | Monitor, Bed Patient | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KMI), ordered by most recent decision date.
LEAF PATIENT MONITORING SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
INTEL-GE CARE INNOVATIONS QUIETCARE
FDA 510(k)
FDA Class 1
·General Hospital
DYNASENSE SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
VIVATRAK
FDA 510(k)
FDA Class 1
·General Hospital
MOBILECARE MONITOR, MODEL 2100
FDA 510(k)
FDA Class 1
·General Hospital
ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by J. T. Posey Co.
| K Number | Device Name | ||
|---|---|---|---|
| K113355 | POSEY BED | May 2, 2012 | Substantially Equivalent |
| K113357 | POSEY BED | Mar 21, 2012 | Substantially Equivalent |
| K103817 | POSEY BED | Apr 22, 2011 | Substantially Equivalent |
| K963414 | MULTIPLE BELTS | Nov 22, 1996 | Substantially Equivalent |
| K963410 | POSEY STRAIGHT JACKETS | Nov 22, 1996 | Substantially Equivalent |
| K963442 | JACKETS AND VESTS | Nov 22, 1996 | Substantially Equivalent |
| K963436 | RESTRAINT ACCESSORIES | Nov 22, 1996 | Substantially Equivalent |
| K963439 | PEDIATRIC LIMB HOLDERS | Nov 19, 1996 | Substantially Equivalent |
| K963437 | PELVIC HOLDERS | Nov 19, 1996 | Substantially Equivalent |
| K963411 | POSEY LAPTOP TRAYS | Nov 19, 1996 | Substantially Equivalent |