Cadwell Apollo System
FDA 510(k) K180269 · Cadwell Industries, Inc.
510(k) numberK180269
Submission
- Device name
- Cadwell Apollo System
- Applicant
- Cadwell Industries, Inc.
Kennewick, WA, US - Received
- January 31, 2018
- Decision date
- July 17, 2018
- 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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| 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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| K250851 | Hypnos (369054-200)OLZ · Traditional | 12/14/2025SE |
| K242424 | Bluebird Single-Use Respiratory Effort BeltMNR · Traditional | 12/18/2024SE |
| K230415 | Cadwell GuardianGWF · Traditional | 08/17/2023SE |
| K201819 | Cadwell Apollo SystemGWQ · Traditional | 09/29/2020SE |
| K192624 | ApneaTrakOLV · Traditional | 02/20/2020SE |
| K190760 | Cadwell Bolt SoftwareOLT · Traditional | 11/23/2019SE |
| K181466 | Cadwell Zenith SystemGWQ · Traditional | 09/01/2018SE |
| K162199 | Cascade IOMAX Intraoperative MonitorGWF · Traditional | 03/02/2017SE |
| K162383 | Cadwell Sierra Summit, Cadwell Sierra AscentIKN · Traditional | 03/01/2017SE |
Questions and answers
When was Cadwell Apollo System cleared by the FDA?
Cadwell Apollo System (K180269) received a 510(k) decision of Substantially Equivalent on July 17, 2018, 167 days after the submission was received.
What is the product code of K180269?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.