FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GRAHAM-FIELD SALINE ELECTROLYTE GEL
K Number: K944600
·
Decision Nov 20, 1995
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
68
Applicant Total
11
Review Days
427
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Basic Information
- Device Name
- GRAHAM-FIELD SALINE ELECTROLYTE GEL
- K Number
- K944600
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chester Labs, Inc.
- Date Received
- September 19, 1994
- Decision Date
- November 20, 1995
- Product Code
- GYB
- 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 |
|---|---|---|---|
| GYB | Media, Electroconductive | FDA class 2 | Neurology |
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Other Clearances by Chester Labs, Inc.
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|---|---|---|---|
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| K001593 | MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL | Jun 14, 2000 | Substantially Equivalent |
| K944599 | GRAHAM-FIELD CONDUCTIVE ECG SPRAY | May 7, 1996 | Substantially Equivalent |
| K944598 | GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL | May 7, 1996 | Substantially Equivalent |
| K944597 | GRAHAM-FIELD ULTRASOUND SCANNING GEL | Jun 21, 1995 | Substantially Equivalent |
| K944596 | GRAHAM-FIELD ULTRASOUND LOTION | Jun 7, 1995 | Substantially Equivalent |
| K940254 | BIOSHIELD BLUE POWDER FREE GLOVE | Mar 23, 1994 | Substantially Equivalent |
| K940256 | BIOSHIELD BLUE LATEX GLOVES | Mar 23, 1994 | Substantially Equivalent |
| K841871 | LIQUA-SONIC GEL | Mar 14, 1985 | Substantially Equivalent |