FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMBULATORY EEG PLAYBACK
K Number: K872183
·
Decision Jul 21, 1987
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
186
Applicant Total
46
Review Days
43
Basic Information
- Device Name
- AMBULATORY EEG PLAYBACK
- K Number
- K872183
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- CADWELL LABORATORIES, INC.
- Date Received
- June 8, 1987
- Decision Date
- July 21, 1987
- Product Code
- GWQ
- 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 |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWQ), ordered by most recent decision date.
Flexset System
FDA 510(k)
FDA Class 2
·Neurology
Neuronaute Plus
FDA 510(k)
FDA Class 2
·Neurology
Q21
FDA 510(k)
FDA Class 2
·Neurology
SPARK Scan
FDA 510(k)
FDA Class 2
·Neurology
Cumulus Functional Neurophysiology Platform
FDA 510(k)
FDA Class 2
·Neurology
Okti
FDA 510(k)
FDA Class 2
·Neurology
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 |
| K040932 | EASYNET BODY POSITION MODULE | Jul 1, 2004 | Substantially Equivalent |
| K040986 | CADWELL LIMB MOVEMENT MODULE | Jul 1, 2004 | Substantially Equivalent |
| K971214 | KILOWIN | Jun 11, 1998 | Substantially Equivalent |
| K962455 | FOUR-CHANNEL PREAMPLIFIER | Jan 13, 1997 | Substantially Equivalent |
| K962458 | CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER | Jan 13, 1997 | Substantially Equivalent |
| K962457 | TWO-CHANNEL PREAMPLIFIER | Jan 13, 1997 | Substantially Equivalent |
| K946094 | CADWELL EASY AMBULATORY EEG | Sep 12, 1995 | Substantially Equivalent |