Sensory Needle Electrode Dne 111-115,116-117,118
FDA 510(k) K894911 · Dantec Electronics, Inc.
510(k) numberK894911
Submission
- Device name
- Sensory Needle Electrode Dne 111-115,116-117,118
- Applicant
- Dantec Electronics, Inc.
Allendale, NJ, US - Received
- August 1, 1989
- Decision date
- May 14, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K895460 | Concentric Electrode Type #13R01, 13R02IKT · Traditional | 06/18/1990SE |
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| K874759 | 13L81 Disposable Sphincter Electrode, 13L33 CableFAP · Traditional | 04/14/1988SE |
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| K874735 | Dantec 13L35/36/37 Stim. and Recording ElectrodeGXY · Traditional | 01/22/1988SE |
| K870567 | Evoport 300GWF · Traditional | 10/06/1987SE |
| K872106 | Dantec CounterpointGWF · Traditional | 09/10/1987SE |
| K860368 | Urdyn 5000 (Uroflowmeter)FFO · Traditional | 04/23/1986SE |
| K853119 | Urodyn 1000FFO · Traditional | 10/04/1985SE |
Questions and answers
When was Sensory Needle Electrode Dne 111-115,116-117,118 cleared by the FDA?
Sensory Needle Electrode Dne 111-115,116-117,118 (K894911) received a 510(k) decision of Substantially Equivalent on May 14, 1990, 286 days after the submission was received.
What is the product code of K894911?
The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.