FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMERGENCY/ACCIDENT TROLLEY 550
K Number: K946101
·
Decision Feb 7, 1995
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
49
Applicant Total
26
Review Days
55
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Basic Information
- Device Name
- EMERGENCY/ACCIDENT TROLLEY 550
- K Number
- K946101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hogan & Hartson
- Date Received
- December 14, 1994
- Decision Date
- February 7, 1995
- Product Code
- FPO
- 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 |
|---|---|---|---|
| FPO | Stretcher, Wheeled | FDA class 2 | General Hospital |
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| K946216 | CARDIOLIPIN A EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
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