The Wonder Box
FDA 510(k) K901797 · Micro Tronics Corp.
510(k) numberK901797
Submission
- Device name
- The Wonder Box
- Applicant
- Micro Tronics Corp.
Carrboro, NC, US - Received
- April 19, 1990
- Decision date
- February 7, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K230148 | VlabGWL · Traditional | Dormotech Medical, Ltd. | 10/11/2023SE |
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| K220631 | NomadAir PMU810GWL · Traditional | Neurotronics, Inc. | 07/15/2022SE |
| K203331 | Quick-20mGWL · Traditional | Cgx, LLC | 05/20/2021SE |
| K202174 | Digital NeuroPort Biopotential Signal Processing SystemGWL · Special | Blackrock Microsystems | 02/10/2021SE |
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| K862527 | Sleep Analyzing ComputerOLZ · Traditional | 10/06/1986SE |
| K780838 | PerciBXX · Traditional | 07/17/1978SE |
| K772005 | Myotone Emg MonitorIKN · Traditional | 11/23/1977SE |
Questions and answers
When was The Wonder Box cleared by the FDA?
The Wonder Box (K901797) received a 510(k) decision of Substantially Equivalent on February 7, 1991, 294 days after the submission was received.
What is the product code of K901797?
The FDA product code is GWL – Amplifier, Physiological Signal, a Class II (moderate risk) device regulated under 21 CFR 882.1835.