CPA/3.5 MHZ Probe
FDA 510(k) K911435 · Diasonics, Inc.
510(k) numberK911435
Submission
- Device name
- CPA/3.5 MHZ Probe
- Applicant
- Diasonics, Inc.
Milipitas, CA, US - Received
- April 2, 1991
- Decision date
- September 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Vitrolife Sweden AB
| 510(k) | Device | Decision |
|---|---|---|
| K962662 | Vingmed Sound Color Flow Mapping SystemIYO · Traditional | 01/02/1997SE |
| K924079 | CFM-800 Color Flow Mapping SystemIYO · Traditional | 09/28/1993SE |
| 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 |
| K891452 | Spectra Ultrasound System W/Color Flow ModuleIYO · Traditional | 06/07/1989SE |
Questions and answers
When was CPA/3.5 MHZ Probe cleared by the FDA?
CPA/3.5 MHZ Probe (K911435) received a 510(k) decision of Substantially Equivalent on September 11, 1992, 528 days after the submission was received.
What is the product code of K911435?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.