FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BABY POD
K Number: K030283
·
Decision Apr 22, 2003
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
38
Applicant Total
4
Review Days
85
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Basic Information
- Device Name
- BABY POD
- K Number
- K030283
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6900
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Prism Enterprises, Inc.
- Date Received
- January 27, 2003
- Decision Date
- April 22, 2003
- Product Code
- FPP
- 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 |
|---|---|---|---|
| FPP | Stretcher, Hand-Carried | FDA class 1 | General Hospital |
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