Acuson I7505 Transducer for Intracavitary Applica.
FDA 510(k) K874860 · Acuson Computed Sonography
510(k) numberK874860
Submission
- Device name
- Acuson I7505 Transducer for Intracavitary Applica.
- Applicant
- Acuson Computed Sonography
Mountain View, CA, US - Received
- November 27, 1987
- Decision date
- February 17, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K874861 | Acuson S328 Transducer for Cardiac Color Flow App.DPT · Traditional | 05/11/1988SE |
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| 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 I7505 Transducer for Intracavitary Applica. cleared by the FDA?
Acuson I7505 Transducer for Intracavitary Applica. (K874860) received a 510(k) decision of Substantially Equivalent on February 17, 1988, 82 days after the submission was received.
What is the product code of K874860?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.