Nicolet Brainlab System
FDA 510(k) K882599 · Nicolet Instrument Corp.
510(k) numberK882599
Submission
- Device name
- Nicolet Brainlab System
- Applicant
- Nicolet Instrument Corp.
Madison, WI, US - Received
- June 24, 1988
- Decision date
- October 19, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Bio-Feedback Systems, Inc.
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| K905632 | Nicolet Mapleleaf SystemGWJ · Traditional | 06/07/1991SE |
| K897154 | Nicolet Dbte Hearing Aid: Digital & ProgrammableESD · Traditional | 04/30/1990SE |
| K894629 | Nicolet Beam II SystemGWS · Traditional | 03/09/1990SE |
| K896477 | Nicolet Real Ear AnalyzerETW · Traditional | 02/08/1990SE |
| K883781 | Nicolet Neuroport/Ace SystemIKN · Traditional | 06/05/1989SE |
| K890495 | Nicolet Viking II SystemIKN · Traditional | 03/16/1989SE |
Questions and answers
When was Nicolet Brainlab System cleared by the FDA?
Nicolet Brainlab System (K882599) received a 510(k) decision of Substantially Equivalent on October 19, 1988, 117 days after the submission was received.
What is the product code of K882599?
The FDA product code is GWK – Conditioner, Signal, Physiological, a Class II (moderate risk) device regulated under 21 CFR 882.1845.