FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADAM
K Number: K033978
·
Decision Feb 18, 2004
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
186
Applicant Total
13
Review Days
57
Basic Information
- Device Name
- ADAM
- K Number
- K033978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ASTRO-MED, INC.
- Date Received
- December 23, 2003
- Decision Date
- February 18, 2004
- 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 ASTRO-MED, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K081551 | TWIN NEUROTRAC-III | Dec 24, 2008 | Substantially Equivalent |
| K050425 | AURA-PSG | Oct 20, 2005 | Substantially Equivalent |
| K970951 | GRASS BRAINWAVE SOFTWARE | May 19, 1997 | Substantially Equivalent |
| K963669 | GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM | Dec 12, 1996 | Substantially Equivalent |
| K934644 | K3 SYSTEM | Nov 1, 1994 | Substantially Equivalent |
| K912929 | DASH IV | Aug 13, 1991 | Substantially Equivalent |
| K896164 | ASC-954 INTEGRATOR AMPLIFIER | Jan 22, 1990 | Substantially Equivalent |
| K894295 | ASTRO-MED ASC-951 PRESSURE PROCESSOR | Jan 18, 1990 | Substantially Equivalent |
| K894736 | MT96000 PAPER CHART RECORDER | Dec 13, 1989 | Substantially Equivalent |
| K894735 | ASC-952 PHYSIOLOGICAL AMPLIFIER | Sep 18, 1989 | Substantially Equivalent |