FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFEBRIDGE
K Number: K111384
·
Decision May 24, 2011
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
83
Applicant Total
3
Review Days
7
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Basic Information
- Device Name
- LIFEBRIDGE
- K Number
- K111384
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lifebridge Medizintechnik AG
- Date Received
- May 17, 2011
- Decision Date
- May 24, 2011
- Product Code
- KFM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | FDA class 2 | Cardiovascular |
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