FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOS. CONDUCTIVE ADHESIVE TENS PAD
K Number: K850311
·
Decision Mar 5, 1985
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
15
Review Days
39
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Basic Information
- Device Name
- DISPOS. CONDUCTIVE ADHESIVE TENS PAD
- K Number
- K850311
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Consolidated Medical Equipment, Inc.
- Date Received
- January 25, 1985
- Decision Date
- March 5, 1985
- 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 Consolidated Medical Equipment, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K854040 | I.V. DRESSING | Jan 9, 1986 | Substantially Equivalent |
| K850132 | DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC | Apr 9, 1985 | Substantially Equivalent |
| K850130 | PRN ECG ELECTRODE | Apr 9, 1985 | Substantially Equivalent |
| K850037 | CLOSED WOUND DRAIN | Mar 19, 1985 | Substantially Equivalent |
| K844942 | PLURA-GARD CHEST DRAINAGE SYSTEM | Mar 12, 1985 | Substantially Equivalent |
| K850131 | CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS | Mar 5, 1985 | Substantially Equivalent |
| K850129 | MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN | Feb 28, 1985 | Substantially Equivalent |
| K850133 | VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. | Feb 28, 1985 | Substantially Equivalent |
| K844372 | HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE | Feb 21, 1985 | Substantially Equivalent |
| K844371 | HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE | Feb 20, 1985 | Substantially Equivalent |