FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRODE, PNS
K Number: K760312
·
Decision Aug 4, 1976
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
11
Review Days
9
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Basic Information
- Device Name
- ELECTRODE, PNS
- K Number
- K760312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Ndm Corp.
- Date Received
- July 26, 1976
- Decision Date
- August 4, 1976
- 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 Ndm Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K926202 | CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI | May 12, 1993 | Substantially Equivalent |
| K901145 | NDM SWITCHPEN HOLSTER | May 9, 1990 | Substantially Equivalent |
| K853968 | DIATEMP ELECTROSURGICAL PEN | Nov 14, 1985 | Substantially Equivalent |
| K830663 | PENCIL SKIN ABRADER | Apr 28, 1983 | Substantially Equivalent |
| K810920 | NDM DIATEMP INFANT ELECTROSURG. DISP. P. | May 1, 1981 | Substantially Equivalent |
| K801158 | NDM DIATEMP ELECTROSURGICAL DIS. PAD | May 23, 1980 | Substantially Equivalent |
| K790730 | NDM PAPER TAPE ECG ELECTRODE | Apr 26, 1979 | Substantially Equivalent |
| K772354 | I.V. CATHETER | Jan 31, 1978 | Substantially Equivalent |
| K772160 | ELECTROSURGICAL GROUNDING PAD | Nov 28, 1977 | Substantially Equivalent |
| K761301 | V-TRACE ECG BACKPAD | Jan 5, 1977 | Substantially Equivalent |