Emg Disc Recording Electrode
FDA 510(k) K953361 · Chalgren Enterprises, Inc.
510(k) numberK953361
Submission
- Device name
- Emg Disc Recording Electrode
- Applicant
- Chalgren Enterprises, Inc.
Gilroy, CA, US - Received
- July 17, 1995
- Decision date
- January 22, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K953356 | Emg Recording Ring ElectrodeGXY · Traditional | 01/22/1996SE |
| K953354 | Emg Disc Recording ElectrodeGXY · Traditional | 01/22/1996SE |
| K952908 | Emg Disc Recording Electrode with PinGXY · Traditional | 12/06/1995SE |
| K952690 | Emg Disc Recording Electrode with PinGXY · Traditional | 12/06/1995SE |
| K953887 | Re-Usable Concentric NeedleIKT · Traditional | 10/31/1995SE |
| K953886 | Re-Usable Monopolar NeedleIKT · Traditional | 10/31/1995SE |
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Questions and answers
When was Emg Disc Recording Electrode cleared by the FDA?
Emg Disc Recording Electrode (K953361) received a 510(k) decision of Substantially Equivalent on January 22, 1996, 189 days after the submission was received.
What is the product code of K953361?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.