FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMG DISC RECORDING ELECTRODE
K Number: K953361
·
Decision Jan 22, 1996
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
21
Review Days
189
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Basic Information
- Device Name
- EMG DISC RECORDING ELECTRODE
- K Number
- K953361
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chalgren Enterprises, Inc.
- Date Received
- July 17, 1995
- Decision Date
- January 22, 1996
- Product Code
- GXY
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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Other Clearances by Chalgren Enterprises, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982950 | FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550 | Jun 22, 1999 | Substantially Equivalent |
| K960591 | RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP | Jun 13, 1996 | Substantially Equivalent |
| K955335 | DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE | Jan 29, 1996 | Substantially Equivalent |
| K953356 | EMG RECORDING RING ELECTRODE | Jan 22, 1996 | Substantially Equivalent |
| K953354 | EMG DISC RECORDING ELECTRODE | Jan 22, 1996 | Substantially Equivalent |
| K952690 | EMG DISC RECORDING ELECTRODE WITH PIN | Dec 6, 1995 | Substantially Equivalent |
| K952908 | EMG DISC RECORDING ELECTRODE WITH PIN | Dec 6, 1995 | Substantially Equivalent |
| K953886 | RE-USABLE MONOPOLAR NEEDLE | Oct 31, 1995 | Substantially Equivalent |
| K953887 | RE-USABLE CONCENTRIC NEEDLE | Oct 31, 1995 | Substantially Equivalent |
| K953219 | 22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN | Oct 6, 1995 | Substantially Equivalent |