Diasonics Cardio/Imaging Echoscope
FDA 510(k) K827573 · Diasonics, Inc.
510(k) numberK827573
Submission
- Device name
- Diasonics Cardio/Imaging Echoscope
- Applicant
- Diasonics, Inc.
Milpitas, CA, US - Received
- July 23, 1982
- Decision date
- August 16, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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|---|---|---|
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| K911435 | CPA/3.5 MHZ ProbeITX · Traditional | 09/11/1992SE |
| K905200 | Saca, 3.5 MHZ ProbeITX · Traditional | 04/02/1992SE |
| K903562 | CW Doppler 2.25 MHZ ProbeITX · Traditional | 03/02/1992SE |
| K903984 | CW DOPPLER/4.5 MHZITX · Traditional | 06/14/1991SE |
| K896637 | Access(Tm), Software Release 4.11PLPH · Traditional | 01/22/1990SE |
| K893518 | Mt/S Software Release 5.0.LNH · Traditional | 10/27/1989SE |
| K894290 | Access TMLNH · Traditional | 09/07/1989SE |
| K893881 | Access TMLNH · Traditional | 06/23/1989SE |
Questions and answers
When was Diasonics Cardio/Imaging Echoscope cleared by the FDA?
Diasonics Cardio/Imaging Echoscope (K827573) received a 510(k) decision of Substantially Equivalent on August 16, 1982, 24 days after the submission was received.