FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY
K Number: K051079
·
Decision May 19, 2005
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
47
Applicant Total
1
Review Days
22
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Basic Information
- Device Name
- HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY
- K Number
- K051079
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hospicare, Inc.
- Date Received
- April 27, 2005
- Decision Date
- May 19, 2005
- Product Code
- MRZ
- 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 |
|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | FDA class 2 | General Hospital |
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