Emg Disc Recording Electrode with Pin
FDA 510(k) K952908 · Chalgren Enterprises, Inc.
510(k) numberK952908
Submission
- Device name
- Emg Disc Recording Electrode with Pin
- Applicant
- Chalgren Enterprises, Inc.
Gilroy, CA, US - Received
- June 23, 1995
- Decision date
- December 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K953354 | Emg Disc Recording ElectrodeGXY · Traditional | 01/22/1996SE |
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| K953887 | Re-Usable Concentric NeedleIKT · Traditional | 10/31/1995SE |
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Questions and answers
When was Emg Disc Recording Electrode with Pin cleared by the FDA?
Emg Disc Recording Electrode with Pin (K952908) received a 510(k) decision of Substantially Equivalent on December 6, 1995, 166 days after the submission was received.
What is the product code of K952908?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.