Deeg-Lite
FDA 510(k) K972202 · Grass-Telefactor Product Group
510(k) numberK972202
Submission
- Device name
- Deeg-Lite
- Applicant
- Grass-Telefactor Product Group
West Conshohocken, PA, US - Received
- June 11, 1997
- Decision date
- July 23, 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
Other 510(k)s with product code GWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)GWQ · Special | Neuroelectrics Barcelona S.L.U. | 06/13/2026SE |
| 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 |
More from iMediSync, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992291 | H20- Tethered OptionOLV · Special | 08/06/1999SE |
| K974583 | DeegliteOLV · Traditional | 06/09/1998SE |
| K974587 | H2OOLV · Traditional | 03/09/1998SE |
| K925838 | Telefactor D/EEG-32GWQ · Traditional | 04/30/1993SE |
| K884937 | BEEHIVE-64 or BEEHIVE-32, Digital EEG RecordingEEG · Traditional | 04/14/1989SE |
| K870432 | A1-A2 Ambulatory EEG Cassette RecorderGWQ · Traditional | 05/08/1987SE |
| K871480 | STD-228 Spectral Trend DisplayGWS · Traditional | 05/01/1987SE |
| K870450 | SZAC-16 Seizure Analysis ComputerOMB · Traditional | 04/08/1987SE |
| K870381 | DD-VCR-64GWK · Traditional | 03/25/1987SE |
| K860219 | Sasssy Semi Automatic Sleep Scoring SystemOLV · Traditional | 04/17/1986SE |
Questions and answers
When was Deeg-Lite cleared by the FDA?
Deeg-Lite (K972202) received a 510(k) decision of Substantially Equivalent on July 23, 1997, 42 days after the submission was received.
What is the product code of K972202?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.