FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)
K Number: K050971
·
Decision Aug 16, 2005
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
83
Applicant Total
3
Review Days
120
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Basic Information
- Device Name
- BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)
- K Number
- K050971
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biovalve Technologies, Inc.
- Date Received
- April 18, 2005
- Decision Date
- August 16, 2005
- Product Code
- LZG
- 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 |
|---|---|---|---|
| LZG | Pump, Infusion, Insulin | FDA class 2 | General Hospital |
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