Elec-Tip
FDA 510(k) K873298 · Etymotic Research
510(k) numberK873298
Submission
- Device name
- Elec-Tip
- Applicant
- Etymotic Research
Elk Grove Village, IL, US - Received
- August 18, 1987
- Decision date
- November 24, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 |
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| K011114 | Etymotic Research ER-10D Oae ProbeEWO · Traditional | 07/03/2001SE |
| K010165 | Ero Scan Oae Test SystemEWO · Traditional | 03/12/2001SE |
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| K930553 | Cub Dis Otoacoustic Emissions Test InstrumentEWO · Traditional | 09/29/1993SE |
| K930003 | Tubephone Models ER-3A & ER-3 Insert EarphonesEWO · Traditional | 06/18/1993SE |
| K861113 | ER-7C Clinical Probe MicrophoneETW · Traditional | 04/23/1986SE |
| K843144 | K-Bass Lo Frequency Hearing AidESD · Traditional | 09/07/1984SE |
Questions and answers
When was Elec-Tip cleared by the FDA?
Elec-Tip (K873298) received a 510(k) decision of Substantially Equivalent on November 24, 1987, 98 days after the submission was received.
What is the product code of K873298?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.