FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND
K Number: K837329
·
Decision Jun 7, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
11
Review Days
91
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Basic Information
- Device Name
- SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND
- K Number
- K837329
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Carolina Medical Electronics
- Date Received
- March 8, 1983
- Decision Date
- June 7, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
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| K864624 | PROBE, UPTAKE, NUCLEAR | Aug 10, 1987 | Substantially Equivalent |
| K843891 | DOPSCAN PLUS DS1060 | Jan 9, 1985 | Substantially Equivalent |
| K820272 | CLINIFLOW II, #701, ELECTROMAGN. BLD. SY | Mar 12, 1982 | Substantially Equivalent |
| K810561 | DOPSCAN MODEL 1050 | Apr 10, 1981 | Substantially Equivalent |
| K801647 | SONACOLOR 6100 | Aug 20, 1980 | Substantially Equivalent |
| K792540 | SONACOLOR 6000 | Jan 17, 1980 | Substantially Equivalent |
| K772015 | PATIENT HEATER SYSTEM, MODEL PH112 | Nov 15, 1977 | Substantially Equivalent |