Acuson L538 Transducer
FDA 510(k) K893863 · Acuson Computed Sonography
510(k) numberK893863
Submission
- Device name
- Acuson L538 Transducer
- Applicant
- Acuson Computed Sonography
Mountain View, CA, US - Received
- May 24, 1989
- Decision date
- May 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Vitrolife Sweden AB
| 510(k) | Device | Decision |
|---|---|---|
| K874028 | Acuson S328 TransducerIYO · Traditional | 06/21/1988SE |
| K874861 | Acuson S328 Transducer for Cardiac Color Flow App.DPT · Traditional | 05/11/1988SE |
| K874363 | Acuson S228 and S328 Transducers for Abdom. Appli.IYO · Traditional | 05/02/1988SE |
| K874922 | Acuson Transperineal Needle GuideITX · Traditional | 02/19/1988SE |
| K874860 | Acuson I7505 Transducer for Intracavitary Applica.ITX · Traditional | 02/17/1988SE |
| K871506 | Acuson L538 TransducerJOP · Traditional | 09/28/1987SE |
| K871416 | Auxiliary Continuous Wave Doppler TransducerJOP · Traditional | 09/28/1987SE |
| K871239 | Acuson Physiological Control ModuleDPS · Traditional | 06/05/1987SE |
| K864578 | Acuson TV519 TransducerHGL · Traditional | 03/27/1987SE |
| K863236 | Acuson S519B Transducer · Traditional | 02/13/1987SE |
Questions and answers
When was Acuson L538 Transducer cleared by the FDA?
Acuson L538 Transducer (K893863) received a 510(k) decision of Substantially Equivalent on May 23, 1990, 364 days after the submission was received.
What is the product code of K893863?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.