FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER AGILITY INTENSIVE CARE BED
K Number: K946149
·
Decision Mar 14, 1995
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
69
Applicant Total
14
Review Days
88
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
- STRYKER AGILITY INTENSIVE CARE BED
- K Number
- K946149
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5100
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Stryker Medical
- Date Received
- December 16, 1994
- Decision Date
- March 14, 1995
- Product Code
- FNL
- 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 |
|---|---|---|---|
| FNL | Bed, Ac-Powered Adjustable Hospital | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FNL), ordered by most recent decision date.
iBed Wireless with iBed Mobile
FDA 510(k)
FDA Class 2
·General Hospital
IBED WIRELESS WITH IBED AWARENESS
FDA 510(k)
FDA Class 2
·General Hospital
VAIL 1000 ENCLOSED BED
FDA 510(k)
FDA Class 2
·General Hospital
MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED
FDA 510(k)
FDA Class 2
·General Hospital
BENEFIT B3--- SERIES
FDA 510(k)
FDA Class 2
·General Hospital
VOLKER HOSPITAL BED, MODEL K960
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Stryker Medical
| K Number | Device Name | ||
|---|---|---|---|
| K222818 | Xpedition Powered Stair Chair (625700000000) | Jan 24, 2023 | Substantially Equivalent |
| K180834 | Altrix Precision Temperature Management System | Aug 10, 2018 | Substantially Equivalent |
| K171149 | Altrix Temperature Management Wraps | Jul 18, 2017 | Substantially Equivalent |
| K152266 | Altrix Precision Temperature Management System | Dec 2, 2016 | Substantially Equivalent |
| K113598 | POWER-LOAD COT FASTENER SYSTEM | Dec 20, 2011 | Substantially Equivalent |
| K943864 | STRYKER 8000 SURGERY STRETCHER | Aug 25, 1994 | Substantially Equivalent |
| K935949 | STRYKER 5000 | Jun 17, 1994 | Substantially Equivalent |
| K941738 | STRYKER 5050 STRECHAIR | May 6, 1994 | Substantially Equivalent |
| K940068 | STRYKER OPERATING ROOM TABLE | May 5, 1994 | Substantially Equivalent |
| K935297 | STRYKER AMBULANCE COT MODEL 6060 | Feb 18, 1994 | Substantially Equivalent |