Life-Tech #5102 Visulab
FDA 510(k) K812180 · Life-Tech Instruments, Inc.
510(k) numberK812180
Submission
- Device name
- Life-Tech #5102 Visulab
- Applicant
- Life-Tech Instruments, Inc.
Mchenry, IL, US - Received
- August 3, 1981
- Decision date
- August 21, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K260566 | SMARTVERTIGO Vestibular Assessment SystemGWN · Traditional | VertigoDx, Inc. | 07/30/2026SE |
| K243709 | NeuroEars-AnnaGWN · Traditional | Neuroears, Inc. | 08/25/2025SE |
| K242198 | ICS Dizcovery (1091)GWN · Traditional | Natus Medical Denmark Aps | 02/14/2025SE |
| K242726 | Synapsys VHITGWN · Traditional | Inventis S.R.L. | 01/03/2025SE |
| K223047 | NeuroSwift ProGWN · Traditional | Neurobit Technologies Co., Ltd. | 06/29/2023SE |
| K203082 | Insight Infrared Video GogglesGWN · Traditional | Vestibular First | 11/12/2020SE |
| K200534 | VisualEyesGWN · Traditional | Interacoustics A/S | 08/12/2020SE |
| K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal…GWN · Traditional | Neurolign USA, LLC | 11/29/2019SE |
| K181771 | RightEye Vision SystemGWN · Traditional | Righteye, LLC | 09/28/2018SE |
| K182214 | DizzyDoctor System 1.0.0GWN · Traditional | Dizzydoctor Systems, LLC | 09/14/2018SE |
More from Dizzydoctor Systems, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K812177 | Life-Tech #1857 Pressure/Polot ModuleEXQ · Traditional | 09/09/1981SE |
| K812179 | Life-Tech #1753 Biofeedback TrainerHCC · Traditional | 08/25/1981SE |
| K812178 | Life-Tech #'S 1106/1156 UrolabsFAP · Traditional | 08/13/1981SE |
| K800112 | Amblyopia TrainerHPL · Traditional | 03/10/1980SE |
| K790663 | Model 1750 Standing UrinalFFG · Traditional | 04/24/1979SE |
| K790664 | Model 1309 Audio MonitorIKN · Traditional | 04/23/1979SE |
| K781476 | Mular Gold Leaf Electrode Model 7501HLZ · Traditional | 11/15/1978SE |
| K781461 | Model 7320 Visual StimulatorGWE · Traditional | 11/08/1978SE |
| K781475 | Electrode Impedance Tester-Model 500GYA · Traditional | 09/07/1978SE |
| K781474 | Preamplifier Models 8101PI & 8102PIEWO · Traditional | 09/07/1978SE |
Questions and answers
When was Life-Tech #5102 Visulab cleared by the FDA?
Life-Tech #5102 Visulab (K812180) received a 510(k) decision of Substantially Equivalent on August 21, 1981, 18 days after the submission was received.
What is the product code of K812180?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.