FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MC INFANT CARE UNIE #PP30
K Number: K950059
·
Decision Feb 10, 1995
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
26
Applicant Total
3
Review Days
35
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Basic Information
- Device Name
- MC INFANT CARE UNIE #PP30
- K Number
- K950059
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5140
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Janco Consulting Services
- Date Received
- January 6, 1995
- Decision Date
- February 10, 1995
- 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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