Echoencephalograph, Digital, 1000
FDA 510(k) K770575 · Storz Instrument Co.
510(k) numberK770575
Submission
- Device name
- Echoencephalograph, Digital, 1000
- Applicant
- Storz Instrument Co.
Mchenry, IL, US - Received
- March 28, 1977
- Decision date
- April 26, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K921863 | Sonos 500, 1000, 1500/SONOS or Ultrasound Imag SysGXW · Traditional | Hewlett-Packard Co. | 09/28/1992SE |
| K903085 | SMS-712NAGXW · Traditional | Toshiba America Medical Systems, In.C | 10/05/1990SE |
| 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 |
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Questions and answers
When was Echoencephalograph, Digital, 1000 cleared by the FDA?
Echoencephalograph, Digital, 1000 (K770575) received a 510(k) decision of Substantially Equivalent on April 26, 1977, 29 days after the submission was received.
What is the product code of K770575?
The FDA product code is GXW – Echoencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1240.