FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSERT EARPHONES
K Number: K862363
·
Decision Sep 17, 1986
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
46
Review Days
86
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Basic Information
- Device Name
- INSERT EARPHONES
- K Number
- K862363
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Cadwell Laboratories, Inc.
- Date Received
- June 23, 1986
- Decision Date
- September 17, 1986
- Product Code
- GWJ
- 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, 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 |
| K971214 | KILOWIN | Jun 11, 1998 | 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 |