TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4— 510(k) K932571
Substantially EquivalentTomey Corporation USA
FDA 510(k) clearance K932571 for TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4, Substantially Equivalent on 1995-08-31. Applicant: Tomey Corporation USA. Device class: 2.
Clearance details
- Applicant
- Tomey Corporation USA
- Product code
- Code GWE
- Device class
- Class 2
- Regulation
- 21 CFR 882.1890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
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