FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINVISION LINEAR ARRAY REAL TIME
K Number: K800653
·
Decision Jul 21, 1980
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
77
Applicant Total
13
Review Days
119
Basic Information
- Device Name
- SINVISION LINEAR ARRAY REAL TIME
- K Number
- K800653
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- KT MEDICAL, INC.
- Date Received
- March 24, 1980
- Decision Date
- July 21, 1980
- Product Code
- DXK
- 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 |
|---|---|---|---|
| DXK | Echocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by KT MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K800652 | MODEL E03 ECHO-OPTHALMOSCOPE | May 14, 1980 | Substantially Equivalent |
| K800101 | 4200 ME ECHOENCEPHALOGRAPH | May 2, 1980 | Substantially Equivalent |
| K800092 | COMBISON COMPUTER | Apr 8, 1980 | Substantially Equivalent |
| K800099 | INTRACULA II | Feb 21, 1980 | Substantially Equivalent |
| K800100 | 7200 MA ECHO-OPHTHALMOSCOPE | Feb 21, 1980 | Substantially Equivalent |
| K800094 | COMBISON 200 & COMBISON 202 | Feb 11, 1980 | Substantially Equivalent |
| K800097 | MINIVASON 9 | Feb 11, 1980 | Substantially Equivalent |
| K800093 | TRANSDUCER | Feb 11, 1980 | Substantially Equivalent |
| K800091 | COMBISON 100-MODEL 100 & 110 | Feb 11, 1980 | Substantially Equivalent |
| K800098 | MINIFETON 200 | Feb 11, 1980 | Substantially Equivalent |