FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMBISON 200 & COMBISON 202
K Number: K800094
·
Decision Feb 11, 1980
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
13
Review Days
28
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Basic Information
- Device Name
- COMBISON 200 & COMBISON 202
- K Number
- K800094
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Kt Medical, Inc.
- Date Received
- January 14, 1980
- Decision Date
- February 11, 1980
- Product Code
- IYO
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Kt Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K800653 | SINVISION LINEAR ARRAY REAL TIME | Jul 21, 1980 | Substantially Equivalent |
| 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 |
| K800100 | 7200 MA ECHO-OPHTHALMOSCOPE | Feb 21, 1980 | Substantially Equivalent |
| K800099 | INTRACULA II | Feb 21, 1980 | Substantially Equivalent |
| K800098 | MINIFETON 200 | Feb 11, 1980 | Substantially Equivalent |
| K800093 | TRANSDUCER | Feb 11, 1980 | Substantially Equivalent |
| K800095 | MGD-3 | Feb 11, 1980 | Substantially Equivalent |
| K800091 | COMBISON 100-MODEL 100 & 110 | Feb 11, 1980 | Substantially Equivalent |