FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
K Number: K062457
·
Decision Sep 21, 2006
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
87
Applicant Total
61
Review Days
29
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Basic Information
- Device Name
- INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
- K Number
- K062457
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Healthcare Corporation
- Date Received
- August 23, 2006
- Decision Date
- September 21, 2006
- Product Code
- MEB
- 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 |
|---|---|---|---|
| MEB | Pump, Infusion, Elastomeric | FDA class 2 | General Hospital |
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