Nicolet Ark System
FDA 510(k) K923315 · Nicolet Instrument Corp.
510(k) numberK923315
Submission
- Device name
- Nicolet Ark System
- Applicant
- Nicolet Instrument Corp.
Madison, WI, US - Received
- July 7, 1992
- Decision date
- November 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K243495 | Natus Ultrapro S100 (982A0594)GWF · Special | Natus Neurology Incorporated | 12/12/2024SE |
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| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)GWF · Traditional | Soterix Medical, Inc. | 03/25/2024SE |
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| K230415 | Cadwell GuardianGWF · Traditional | Cadwell Industries, Inc. | 08/17/2023SE |
| K213849 | SafeOp 2: Neural Informatix SystemGWF · Traditional | Alphatec Spine, Inc. | 03/09/2022SE |
More from Alphatec Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921138 | Nicolet Ultrasom Acquisition StationGWQ · Traditional | 05/14/1993SE |
| 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 |
| K884294 | Nicolet Nystar Plus SystemGWN · Traditional | 11/23/1988SE |
Questions and answers
When was Nicolet Ark System cleared by the FDA?
Nicolet Ark System (K923315) received a 510(k) decision of Substantially Equivalent on November 23, 1992, 139 days after the submission was received.
What is the product code of K923315?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.