FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER ADEL BASSINET
K Number: K960012
·
Decision Mar 25, 1996
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
26
Applicant Total
124
Review Days
83
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Basic Information
- Device Name
- STRYKER ADEL BASSINET
- K Number
- K960012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5140
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Stryker Corp.
- Date Received
- January 2, 1996
- Decision Date
- March 25, 1996
- Product Code
- FMS
- 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 |
|---|---|---|---|
| FMS | Bed, Pediatric Open Hospital | FDA class 2 | General Hospital |
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