Nicolet Neuroport/Ace System
FDA 510(k) K883781 · Nicolet Instrument Corp.
510(k) numberK883781
Submission
- Device name
- Nicolet Neuroport/Ace System
- Applicant
- Nicolet Instrument Corp.
Madison, WI, US - Received
- September 6, 1988
- Decision date
- June 5, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IKN – Electromyograph, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Specialty
- Physical Medicine
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| 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 |
| K890495 | Nicolet Viking II SystemIKN · Traditional | 03/16/1989SE |
| K884294 | Nicolet Nystar Plus SystemGWN · Traditional | 11/23/1988SE |
Questions and answers
When was Nicolet Neuroport/Ace System cleared by the FDA?
Nicolet Neuroport/Ace System (K883781) received a 510(k) decision of Substantially Equivalent on June 5, 1989, 272 days after the submission was received.
What is the product code of K883781?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.