FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EEG ANALYZER
K Number: K925735
·
Decision Dec 3, 1993
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
14
Applicant Total
6
Review Days
385
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EEG ANALYZER
- K Number
- K925735
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1420
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio-Scan, Inc.
- Date Received
- November 13, 1992
- Decision Date
- December 3, 1993
- Product Code
- GWS
- 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 |
|---|---|---|---|
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | FDA class 1 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWS), ordered by most recent decision date.
PERSYST PRISM
FDA 510(k)
FDA Class 1
·Neurology
RHYTHM
FDA 510(k)
FDA Class 1
·Neurology
NICOLET BEAM II SYSTEM
FDA 510(k)
FDA Class 1
·Neurology
ISTAT SOFTWARE
FDA 510(k)
FDA Class 1
·Neurology
STD-228 SPECTRAL TREND DISPLAY
FDA 510(k)
FDA Class 1
·Neurology
OEE_7102 EEG/TREND MONITOR
FDA 510(k)
FDA Class 1
·Neurology
Other Clearances by Bio-Scan, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003480 | BIOFIND | May 11, 2001 | Substantially Equivalent |
| K864928 | BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER | Mar 31, 1987 | Substantially Equivalent |
| K841685 | EEG ELECTRODES | Jun 7, 1984 | Substantially Equivalent |
| K841684 | BIO/SCAN BIOLOG CASSETTE RECORDER | Jun 7, 1984 | Substantially Equivalent |
| K841683 | Q.P. PREAMPLIFIER SYS | Jun 7, 1984 | Substantially Equivalent |