FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Giraffe Incubator Carestation CS1
K Number: K152809
·
Decision Dec 31, 2015
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
3
Review Days
94
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Basic Information
- Device Name
- Giraffe Incubator Carestation CS1
- K Number
- K152809
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
- Date Received
- September 28, 2015
- Decision Date
- December 31, 2015
- Product Code
- FMZ
- 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 |
|---|---|---|---|
| FMZ | Incubator, Neonatal | FDA class 2 | General Hospital |
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