SMS-712NA
FDA 510(k) K903085 · Toshiba America Medical Systems, In.C
510(k) numberK903085
Submission
- Device name
- SMS-712NA
- Applicant
- Toshiba America Medical Systems, In.C
Tustin, CA, US - Received
- July 12, 1990
- Decision date
- October 5, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GXW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921863 | Sonos 500, 1000, 1500/SONOS or Ultrasound Imag SysGXW · Traditional | Hewlett-Packard Co. | 09/28/1992SE |
| K853432 | 5.0 Iop & 7.5 Iop ProbesGXW · Traditional | Diasonics, Inc. | 02/07/1986SE |
| K833522 | Neuro Sector Fixation DeviceGXW · Traditional | Advanced Technology Laboratories, Inc. | 05/25/1984SE |
| K821736 | Echo-Pulse KM555GXW · Traditional | Rabar, Inc. | 12/09/1982SE |
| K770788 | Echoencephalograph, DIGITAL,DIGIECHO2000GXW · Traditional | Storz Instrument Co. | 05/06/1977SE |
| K770575 | Echoencephalograph, Digital, 1000GXW · Traditional | Storz Instrument Co. | 04/26/1977SE |
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Questions and answers
When was SMS-712NA cleared by the FDA?
SMS-712NA (K903085) received a 510(k) decision of Substantially Equivalent on October 5, 1990, 85 days after the submission was received.
What is the product code of K903085?
The FDA product code is GXW – Echoencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1240.