Galileo Evoked Potentialre
FDA 510(k) K963662 · Biosound, Inc.
510(k) numberK963662
Submission
- Device name
- Galileo Evoked Potentialre
- Applicant
- Biosound, Inc.
Indianapolis, IN, US - Received
- September 13, 1996
- Decision date
- February 26, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Alphatec Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971700 | Biopsy Accessory for Ultrasound TransducerITX · Traditional | 07/09/1997SE |
| K963936 | Accesspoint, Med E-Mail, Dicom ReaderLMB · Traditional | 03/31/1997SE |
| K963262 | Artoscan MLNH · Traditional | 03/28/1997SE |
| K953716 | Intracavity TransducersITX · Traditional | 04/17/1996SE |
| K953530 | Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-AIYO · Traditional | 04/08/1996SE |
| K953819 | Diagnostic Ultrasound TranducerITX · Traditional | 03/01/1996SE |
| K953759 | Diagnostic Ultrasound TransducerITX · Traditional | 03/01/1996SE |
| K955458 | Ultrasound Probe Biopsy AccessoriesITX · Traditional | 02/12/1996SE |
| K953579 | Tee ProbeITX · Traditional | 02/02/1996SE |
| K953430 | Ultrasound Probe Biopsy AccessoriesITX · Traditional | 10/24/1995SE |
Questions and answers
When was Galileo Evoked Potentialre cleared by the FDA?
Galileo Evoked Potentialre (K963662) received a 510(k) decision of Substantially Equivalent on February 26, 1997, 166 days after the submission was received.
What is the product code of K963662?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.