Concentric Electrode Type #13R01, 13R02
FDA 510(k) K895460 · Dantec Electronics, Inc.
510(k) numberK895460
Submission
- Device name
- Concentric Electrode Type #13R01, 13R02
- Applicant
- Dantec Electronics, Inc.
Allendale, NJ, US - Received
- September 6, 1989
- Decision date
- June 18, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IKT – Electrode, Needle, Diagnostic Electromyograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1385
- Specialty
- Physical Medicine
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| K112034 | Teca Elite Disposable Concentric NeedlesIKT · Special | Carefusion 209, Inc. | 08/12/2011SE |
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More from Ambu A/S
| 510(k) | Device | Decision |
|---|---|---|
| K894911 | Sensory Needle Electrode Dne 111-115,116-117,118GXZ · Traditional | 05/14/1990SE |
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| K881915 | Dantec Magnetic StimulatorGWF · Traditional | 10/17/1988SE |
| K874759 | 13L81 Disposable Sphincter Electrode, 13L33 CableFAP · Traditional | 04/14/1988SE |
| K874758 | Dantec 13L40 St. Marks's Pudendal ElectrodeFAP · Traditional | 04/14/1988SE |
| 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 Concentric Electrode Type #13R01, 13R02 cleared by the FDA?
Concentric Electrode Type #13R01, 13R02 (K895460) received a 510(k) decision of Substantially Equivalent on June 18, 1990, 285 days after the submission was received.
What is the product code of K895460?
The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.