FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KMA FLOW DIRECTED THERMODILUTION CATHETE
K Number: K800836
·
Decision Apr 24, 1980
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
36
Applicant Total
3
Review Days
9
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Basic Information
- Device Name
- KMA FLOW DIRECTED THERMODILUTION CATHETE
- K Number
- K800836
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1915
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Kma, Inc.
- Date Received
- April 15, 1980
- Decision Date
- April 24, 1980
- Product Code
- KRB
- 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 |
|---|---|---|---|
| KRB | Probe, Thermodilution | FDA class 2 | Cardiovascular |
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