TOMEY PE-300 PORTABLE ERG— 510(k) K921815
Substantially EquivalentTomey Corporation USA
FDA 510(k) clearance K921815 for TOMEY PE-300 PORTABLE ERG, Substantially Equivalent on 1992-07-15. Applicant: Tomey Corporation USA. Device class: 2.
Clearance details
- Applicant
- Tomey Corporation USA
- Product code
- Code HLT
- Device class
- Class 2
- Regulation
- 21 CFR 886.1640
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
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