Nicolet Nystar Plus System
FDA 510(k) K884294 · Nicolet Instrument Corp.
510(k) numberK884294
Submission
- Device name
- Nicolet Nystar Plus System
- Applicant
- Nicolet Instrument Corp.
Madison, WI, US - Received
- October 12, 1988
- Decision date
- November 23, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Dizzydoctor Systems, LLC
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| K921138 | Nicolet Ultrasom Acquisition StationGWQ · Traditional | 05/14/1993SE |
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| K921927 | Nicolet VoyageurGWQ · Traditional | 11/05/1992SE |
| K915652 | Nicolet Poratble Spirit SystemGWF · Traditional | 02/07/1992SE |
| 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 Nystar Plus System cleared by the FDA?
Nicolet Nystar Plus System (K884294) received a 510(k) decision of Substantially Equivalent on November 23, 1988, 42 days after the submission was received.
What is the product code of K884294?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.