Galileo Halley
FDA 510(k) K970703 · Biosound Esaote, Inc.
510(k) numberK970703
Submission
- Device name
- Galileo Halley
- Applicant
- Biosound Esaote, Inc.
Indianapolis, IN, US - Received
- February 26, 1997
- Decision date
- May 19, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GWQ – Full-Montage Standard Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
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| K260455 | New Wave SystemGWQ · Special | Zeto, Inc. | 03/13/2026SE |
| K233403 | Flexset SystemGWQ · Traditional | Zeto, Inc. | 04/30/2024SE |
| K231366 | Neuronaute PlusGWQ · Traditional | Bioserenity Sas | 11/09/2023SE |
| K221959 | Q21GWQ · Traditional | Neurofield, Inc. | 08/31/2023SE |
| K231457 | SPARK ScanGWQ · Traditional | Spark Neuro, Inc. | 08/18/2023SE |
| K221963 | Cumulus Functional Neurophysiology PlatformGWQ · Traditional | Cumulus Neuroscience Limited | 04/27/2023SE |
| K230073 | OktiGWQ · Traditional | Compumedics Limited | 02/09/2023SE |
| K223644 | Neuronaute with IceCap 2 & IceCap 2 SmallGWQ · Special | Bioserenity | 01/12/2023SE |
| K220056 | iSyncWaveGWQ · Traditional | iMediSync, Inc. | 08/10/2022SE |
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|---|---|---|
| K023255 | Technos MP, Model AU6IYN · Traditional | 02/11/2003SE |
| K014168 | AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and…IYN · Traditional | 04/25/2002SE |
| K020164 | E-Scan XQLNH · Special | 02/12/2002SE |
| K012728 | E-Scan MRI SystemMOS · Special | 08/29/2001SE |
| K010405 | 7230 Ultrasound Imaging System with TeiIYN · Traditional | 03/13/2001SE |
| K010057 | Modification to Artoscan MLNH · Special | 02/02/2001SE |
| K001894 | Modification to E-ScanLNH · Special | 07/06/2000SE |
| K000931 | AU5 Ultrasound Imaging SystemIYN · Traditional | 06/08/2000SE |
| K000681 | AU5, AU6IYO · Traditional | 05/03/2000SE |
| K994369 | 7250 (Megas)IYN · Traditional | 02/24/2000SE |
Questions and answers
When was Galileo Halley cleared by the FDA?
Galileo Halley (K970703) received a 510(k) decision of Substantially Equivalent on May 19, 1997, 82 days after the submission was received.
What is the product code of K970703?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.