FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
K-10-VS, DA-05-VS, RECORDING ELECTRODES
K Number: K941568
·
Decision Nov 4, 1994
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
14
Review Days
218
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Basic Information
- Device Name
- K-10-VS, DA-05-VS, RECORDING ELECTRODES
- K Number
- K941568
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medicotest, Inc.
- Date Received
- March 31, 1994
- Decision Date
- November 4, 1994
- 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 Medicotest, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983597 | NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES | Jan 11, 1999 | Substantially Equivalent |
| K970639 | NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K | May 15, 1997 | Substantially Equivalent |
| K961643 | MEDICOTEST ECG ELECTRODES | Dec 9, 1996 | Substantially Equivalent |
| K952176 | DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K | Sep 25, 1995 | Substantially Equivalent |
| K931426 | NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODE | Dec 21, 1993 | Substantially Equivalent |
| K931430 | CUTANEOUS ELECTRODE | Dec 21, 1993 | Substantially Equivalent |
| K926264 | MEDICOTEST SKIN FIX | Apr 20, 1993 | Substantially Equivalent |
| K921579 | BR-50-J DISPOSABLE ECG ELECTRODE | May 26, 1992 | Substantially Equivalent |
| K914672 | QR-50-E DISPOSABLE RADIOTRANSLUCENT ECG ELECTRODE | Oct 31, 1991 | Substantially Equivalent |
| K902407 | NF-50-E DISPOSABLE ECG ELECTRODE | Jul 31, 1990 | Substantially Equivalent |