Audio Monitor-Model 8309
FDA 510(k) K780538 · Life-Tech Instruments, Inc.
510(k) numberK780538
Submission
- Device name
- Audio Monitor-Model 8309
- Applicant
- Life-Tech Instruments, Inc.
Mchenry, IL, US - Received
- April 3, 1978
- Decision date
- April 19, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Grass-Telefactor Product Group
| 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 |
| K812180 | Life-Tech #5102 VisulabGWN · Traditional | 08/21/1981SE |
| 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 |
Questions and answers
When was Audio Monitor-Model 8309 cleared by the FDA?
Audio Monitor-Model 8309 (K780538) received a 510(k) decision of Substantially Equivalent on April 19, 1978, 16 days after the submission was received.
What is the product code of K780538?
The FDA product code is GWK – Conditioner, Signal, Physiological, a Class II (moderate risk) device regulated under 21 CFR 882.1845.