FDA 510(k)
Substantially Equivalent
🇺🇸 United States
IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM
K Number: K827370
·
Decision Jun 28, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
10
Review Days
77
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Basic Information
- Device Name
- IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM
- K Number
- K827370
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Irex Corp.
- Date Received
- April 12, 1982
- Decision Date
- June 28, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
Other Clearances by Irex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K844404 | IREX PS, PORTABLE SCANNER AND 118 | Feb 4, 1985 | Substantially Equivalent |
| K843643 | COLOR DOPPLER 880 | Jan 31, 1985 | Substantially Equivalent |
| K842408 | IREX 730 MECHANICAL SECTOR SCANNER | Nov 29, 1984 | Substantially Equivalent |
| K840139 | IREX 720 SECTOR SCANNER | May 9, 1984 | 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 |