FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20
K Number: K902723
·
Decision Dec 13, 1990
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
95
Applicant Total
41
Review Days
177
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Basic Information
- Device Name
- ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20
- K Number
- K902723
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4260
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Electromedics, Inc.
- Date Received
- June 19, 1990
- Decision Date
- December 13, 1990
- Product Code
- DTM
- 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 |
|---|---|---|---|
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | FDA class 2 | Cardiovascular |
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