FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BEL BLOOD LEVEL DETECTOR
K Number: K823712
·
Decision Feb 7, 1983
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
16
Applicant Total
1
Review Days
59
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Basic Information
- Device Name
- BEL BLOOD LEVEL DETECTOR
- K Number
- K823712
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- R. Scott Bell
- Date Received
- December 10, 1982
- Decision Date
- February 7, 1983
- Product Code
- DTW
- 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 |
|---|---|---|---|
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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