FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALARIS SYSTEM WITH MMS, MODEL 8XXX
K Number: K072105
·
Decision Dec 28, 2007
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
844
Applicant Total
4
Review Days
150
Basic Information
- Device Name
- ALARIS SYSTEM WITH MMS, MODEL 8XXX
- K Number
- K072105
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CARDINAL HEALTH 303, INC.
- Date Received
- July 31, 2007
- Decision Date
- December 28, 2007
- Product Code
- FRN
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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