FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇮 Finland
OPTIMA DELIVERY BED (MODELS 33901, 33903, 33902, 33905)
K Number: K944929
·
Decision Nov 22, 1994
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
0
Applicant Total
4
Review Days
47
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Basic Information
- Device Name
- OPTIMA DELIVERY BED (MODELS 33901, 33903, 33902, 33905)
- K Number
- K944929
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5110
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Merivaara Instrumentarium Corp.
- Date Received
- October 6, 1994
- Decision Date
- November 22, 1994
- Product Code
- FNK
- 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 |
|---|---|---|---|
| FNK | Bed, Hydraulic, Adjustable Hospital | FDA class 1 | General Hospital |