Vlab
FDA 510(k) K230148 · Dormotech Medical, Ltd.
510(k) numberK230148
Submission
- Device name
- Vlab
- Applicant
- Dormotech Medical, Ltd.
Afula, IL - Received
- January 19, 2023
- Decision date
- October 11, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K243746 | Delphi AmplifierGWL · Traditional | Quantalx Neroscience | 03/12/2025SE |
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| K223676 | SomniCheckGWL · Traditional | Brainmatterz, LLC | 06/01/2023SE |
| 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 |
| K201747 | 8-CH Electroencephalography AmplifierGWL · Traditional | Hipposcreen Neurotech Corp. | 12/27/2020SE |
More from Hipposcreen Neurotech Corp.
| 510(k) | Device | Decision |
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| K242290 | DormoTech NLabMNR · Traditional | 01/08/2025SE |
Questions and answers
When was Vlab cleared by the FDA?
Vlab (K230148) received a 510(k) decision of Substantially Equivalent on October 11, 2023, 265 days after the submission was received.
What is the product code of K230148?
The FDA product code is GWL – Amplifier, Physiological Signal, a Class II (moderate risk) device regulated under 21 CFR 882.1835.