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510(k) K921815

Device
TOMEY PE-300 PORTABLE ERG
Applicant
TOMEY CORPORATION USA
510(k) number
K921815
Product code
HLT  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-15
Date received
1992-04-15
Regulation
886.1640
Classification name
Preamplifier, Ac-powered, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LORI A TRUITT
Address
325 Vassar St. 2nd Floor Cambridge MA US 02139 02139

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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