Ear Electrode-Adult & Pediatric
FDA 510(k) K780537 · Life-Tech Instruments, Inc.
510(k) numberK780537
Submission
- Device name
- Ear Electrode-Adult & Pediatric
- Applicant
- Life-Tech Instruments, Inc.
Mchenry, IL, US - Received
- April 3, 1978
- Decision date
- June 2, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K261522 | BioWave BioWrapsGXY · Special | Biowave Corporation | 06/03/2026SE |
| K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)GXY · Traditional | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | 05/08/2026SE |
| K254183 | MR Conditional Cup ElectrodesGXY · Traditional | Technomed Europe | 05/07/2026SE |
| K252439 | Tutamen Self Adhesive ElectrodesGXY · Traditional | Dongguan Tutamen Metalwork Co., Ltd. | 05/01/2026SE |
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial…GXY · Traditional | Otto Bock Healthcare Products GmbH | 04/22/2026SE |
| K260363 | Ceribell Brain Monitor HeadbandGXY · Abbreviated | Ceribell, Inc. | 04/03/2026SE |
| K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)GXY · Special | Bionit Labs Srl | 03/12/2026SE |
More from Bionit Labs Srl
| 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 Ear Electrode-Adult & Pediatric cleared by the FDA?
Ear Electrode-Adult & Pediatric (K780537) received a 510(k) decision of Substantially Equivalent on June 2, 1978, 60 days after the submission was received.
What is the product code of K780537?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.