Bwiii EEG, Bwiii EEG Plus, Bwiii PSG, Bwiii PSG Plus
FDA 510(k) K112107 · Neurovirtual USA, Inc.
510(k) numberK112107
Submission
- Device name
- Bwiii EEG, Bwiii EEG Plus, Bwiii PSG, Bwiii PSG Plus
- Applicant
- Neurovirtual USA, Inc.
Doral, FL, US - Received
- July 22, 2011
- Decision date
- October 28, 2011
- 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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| K191095 | Maxxi Snore SensorMNR · Traditional | 01/16/2020SE |
| K171304 | Maxxi Rip SensorMNR · Traditional | 06/24/2019SE |
| K163547 | MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96GXY · Traditional | 04/11/2017SE |
| K131335 | Bwmini EEG, Bwminihst, Bwmini PSGGWQ · Traditional | 02/03/2015SE |
| K062533 | Bwii EEG Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524OLT · Traditional | 12/22/2006SE |
Questions and answers
When was Bwiii EEG, Bwiii EEG Plus, Bwiii PSG, Bwiii PSG Plus cleared by the FDA?
Bwiii EEG, Bwiii EEG Plus, Bwiii PSG, Bwiii PSG Plus (K112107) received a 510(k) decision of Substantially Equivalent on October 28, 2011, 98 days after the submission was received.
What is the product code of K112107?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.