FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
V-505 INFA WARMER
K Number: K060461
·
Decision Apr 28, 2006
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
3
Review Days
65
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Basic Information
- Device Name
- V-505 INFA WARMER
- K Number
- K060461
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Atom Medical, Inc.
- Date Received
- February 22, 2006
- Decision Date
- April 28, 2006
- Product Code
- FMT
- 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 |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | FDA class 2 | General Hospital |
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