FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOMA SAFE ENCLOSURE
K Number: K963701
·
Decision Jan 24, 1997
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
69
Applicant Total
3
Review Days
130
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Basic Information
- Device Name
- SOMA SAFE ENCLOSURE
- K Number
- K963701
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5100
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nova Technology Corp.
- Date Received
- September 16, 1996
- Decision Date
- January 24, 1997
- 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 |
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