510(k) K001069— MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
Substantially EquivalentPhysiometrix, Inc.
Clearance details
- Applicant
- Physiometrix, Inc.
- Product code
- Code OLW
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Billerica, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.