L328 Transducer
FDA 510(k) K905456 · Acuson Corp.
510(k) numberK905456
Submission
- Device name
- L328 Transducer
- Applicant
- Acuson Corp.
Mountain View, CA, US - Received
- December 4, 1990
- Decision date
- May 28, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MAA – Monitor, Fetal Doppler Ultrasound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MAA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102138 | Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerMAA · Traditional | Edan Instruments, Inc. | 10/28/2010SE |
| K090499 | Lifedop Model, L350RMAA · Traditional | Summit Doppler Systems, Inc. | 03/31/2009SE |
| K915138 | GE SonochromeMAA · Traditional | GE Medical Systems | 10/20/1992SE |
| K905536 | Fetal DopplerMAA · Traditional | Toshiba America Medical Systems, In.C | 04/21/1992SE |
| K904600 | L582 TransducerMAA · Traditional | Acuson Corp. | 06/24/1991SE |
| K904951 | S5192R TransducerMAA · Traditional | Acuson Corp. | 04/29/1991SE |
| K895909 | Sonicaid Model Vasoflo 4MAA · Traditional | Oxford Medilog, Inc. | 07/09/1990SE |
| K894992 | Quantum Qad Angiodynograph Ultrasound SystemMAA · Traditional | Quantum Medical Systems, Inc. | 02/23/1990SE |
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| K021497 | Cypress Ultrasound SystemIYN · Special | 07/09/2002SE |
| K010950 | Cypress SystemIYO · Abbreviated | 06/27/2001SE |
| K002807 | 3D Organ Assessment W/ Magnetic Position SensingIYO · Traditional | 12/01/2000SE |
| K992631 | Acunav Diagnostic Ultrasound CatheterDQO · Traditional | 12/15/1999SE |
| K992580 | Fetal Assessment CapIYO · Traditional | 10/18/1999SE |
| K991805 | Aspen Ultrasound with Freestyle Imaging OptionIYN · Traditional | 08/02/1999SE |
| K973767 | Harmonic Imaging with ContrastIYO · Traditional | 12/23/1997SE |
Questions and answers
When was L328 Transducer cleared by the FDA?
L328 Transducer (K905456) received a 510(k) decision of Substantially Equivalent on May 28, 1991, 175 days after the submission was received.
What is the product code of K905456?
The FDA product code is MAA – Monitor, Fetal Doppler Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 884.2660.