Bravo Multi-Modality System
FDA 510(k) K991054 · Nicolet Biomedical, Inc.
510(k) numberK991054
Submission
- Device name
- Bravo Multi-Modality System
- Applicant
- Nicolet Biomedical, Inc.
Madison, WI, US - Received
- March 30, 1999
- Decision date
- November 3, 1999
- 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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| 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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| K021144 | Subdural Strip ElectrodeGYC · Abbreviated | 06/24/2002SE |
| K020218 | Snap EEG MonitorOLW · Abbreviated | 04/22/2002SE |
| K013281 | Versalab ApmHGM · Abbreviated | 04/18/2002SE |
| K020955 | Nicolet Electrocautery DetectorETN · Abbreviated | 04/17/2002SE |
| K013419 | Nicolet Electromagnetic Navigation SystemLLZ · Traditional | 12/20/2001SE |
| K011823 | Biorehab SystemHCC · Abbreviated | 09/06/2001SE |
| K011818 | Sterile Emg ElectrodesIKT · Abbreviated | 09/06/2001SE |
| K011135 | Gsi AuderaEWO · Traditional | 07/26/2001SE |
Questions and answers
When was Bravo Multi-Modality System cleared by the FDA?
Bravo Multi-Modality System (K991054) received a 510(k) decision of Substantially Equivalent on November 3, 1999, 218 days after the submission was received.
What is the product code of K991054?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.