← FDA Medical Device Classifications
Analyzer, Spectrum, Electroencephalogram Signal
GWS · Class I — Low Risk (general controls) · Neurology · 21 CFR 882.1420
Classification
- FDA Product Code
GWS- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 882.1420
- Review panel
- NE
- Medical specialty
- Neurology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Market data
- Cleared 510(k) submissions
- 15
- Registered establishments
- 9
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown