FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLOR DOPPLER 880
K Number: K843643
·
Decision Jan 31, 1985
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
77
Applicant Total
10
Review Days
136
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Basic Information
- Device Name
- COLOR DOPPLER 880
- K Number
- K843643
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Irex Corp.
- Date Received
- September 17, 1984
- Decision Date
- January 31, 1985
- 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 Irex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K844404 | IREX PS, PORTABLE SCANNER AND 118 | Feb 4, 1985 | Substantially Equivalent |
| K842408 | IREX 730 MECHANICAL SECTOR SCANNER | Nov 29, 1984 | Substantially Equivalent |
| K840139 | IREX 720 SECTOR SCANNER | May 9, 1984 | Substantially Equivalent |
| K827370 | IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM | Jun 28, 1982 | Substantially Equivalent |
| K813544 | IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS. | Feb 5, 1982 | Substantially Equivalent |
| K811246 | DOPPLER ULTRASOUND BLOOD FLOWMETER | Aug 12, 1981 | Substantially Equivalent |
| K792525 | IREX CARDIOPLAN | Dec 27, 1979 | Substantially Equivalent |
| K791317 | IREX REAL TIME PHASED ARRAY SYSTEM | Sep 17, 1979 | Substantially Equivalent |
| K771372 | SYSTEM II | Aug 4, 1977 | Substantially Equivalent |