Neuro-Aide
FDA 510(k) K942926 · Burke Neutech, Inc.
510(k) numberK942926
Submission
- Device name
- Neuro-Aide
- Applicant
- Burke Neutech, Inc.
Largo, FL, US - Received
- June 22, 1994
- Decision date
- August 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K851749 | 1-380 Pinwheel (Wartenberg)GWY · Traditional | Artiberia | 06/13/1985SE |
| K780422 | PinwheelGWY · Traditional | Projects IN Health | 04/04/1978SE |
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Questions and answers
When was Neuro-Aide cleared by the FDA?
Neuro-Aide (K942926) received a 510(k) decision of Substantially Equivalent on August 3, 1994, 42 days after the submission was received.
What is the product code of K942926?
The FDA product code is GWY – Pinwheel, a Class I (low risk) device regulated under 21 CFR 882.1750.