Dantec Monopolar Lumen Electrode (13R18 and 13R19)
FDA 510(k) K950314 · Dantec Medical, Inc.
510(k) numberK950314
Submission
- Device name
- Dantec Monopolar Lumen Electrode (13R18 and 13R19)
- Applicant
- Dantec Medical, Inc.
Washington, DC, US - Received
- January 26, 1995
- Decision date
- March 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K932059 | Needle Electrodes and Disposable Scalp ElectrodeIKT · Traditional | 10/04/1994SE |
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| K931966 | Dantec Disposable Concentric NeedleIKT · Traditional | 03/30/1994SE |
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Questions and answers
When was Dantec Monopolar Lumen Electrode (13R18 and 13R19) cleared by the FDA?
Dantec Monopolar Lumen Electrode (13R18 and 13R19) (K950314) received a 510(k) decision of Substantially Equivalent on March 25, 1996, 424 days after the submission was received.
What is the product code of K950314?
The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.