FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KILOWIN
K Number: K971214
·
Decision Jun 11, 1998
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
48
Applicant Total
46
Review Days
435
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Basic Information
- Device Name
- KILOWIN
- K Number
- K971214
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cadwell Laboratories, Inc.
- Date Received
- April 2, 1997
- Decision Date
- June 11, 1998
- Product Code
- GWE
- 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 |
|---|---|---|---|
| GWE | Stimulator, Photic, Evoked Response | FDA class 2 | Neurology |
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Other Clearances by Cadwell Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K061706 | CADWELL EASYNET OXIMETER MODULE | Mar 5, 2007 | Substantially Equivalent |
| K061705 | CADWELL EASYNET NASAL PRESSURE MODULE | Nov 21, 2006 | Substantially Equivalent |
| K042350 | TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR | Nov 3, 2004 | Substantially Equivalent |
| K040986 | CADWELL LIMB MOVEMENT MODULE | Jul 1, 2004 | Substantially Equivalent |
| K040932 | EASYNET BODY POSITION MODULE | Jul 1, 2004 | Substantially Equivalent |
| K962455 | FOUR-CHANNEL PREAMPLIFIER | Jan 13, 1997 | Substantially Equivalent |
| K962457 | TWO-CHANNEL PREAMPLIFIER | Jan 13, 1997 | Substantially Equivalent |
| K962458 | CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER | Jan 13, 1997 | Substantially Equivalent |
| K946094 | CADWELL EASY AMBULATORY EEG | Sep 12, 1995 | Substantially Equivalent |
| K933808 | EEG CUP ELECTRODE | Dec 29, 1994 | Substantially Equivalent |