FDA 510(k)
Substantially Equivalent
🇺🇸 United States
DIASONICS CARDIO/IMAGING ECHOSCOPE
K Number: K827573
·
Decision Aug 16, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
42
Review Days
24
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Basic Information
- Device Name
- DIASONICS CARDIO/IMAGING ECHOSCOPE
- K Number
- K827573
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Diasonics, Inc.
- Date Received
- July 23, 1982
- Decision Date
- August 16, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
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| K911435 | CPA/3.5 MHZ PROBE | Sep 11, 1992 | Substantially Equivalent |
| K905200 | SACA, 3.5 MHZ PROBE | Apr 2, 1992 | Substantially Equivalent |
| K903562 | CW DOPPLER 2.25 MHZ PROBE | Mar 2, 1992 | Substantially Equivalent |
| K903984 | CW DOPPLER/4.5 MHZ | Jun 14, 1991 | Substantially Equivalent |
| K896637 | ACCESS(TM), SOFTWARE RELEASE 4.11P | Jan 22, 1990 | Substantially Equivalent |
| K893518 | MT/S SOFTWARE RELEASE 5.0. | Oct 27, 1989 | Substantially Equivalent |
| K894290 | ACCESS TM | Sep 7, 1989 | Substantially Equivalent |
| K893881 | ACCESS TM | Jun 23, 1989 | Substantially Equivalent |