EPHAR

System, Alarm, Electrosurgical

AKRON CITY HOSPITAL

The following data is part of a premarket notification filed by Akron City Hospital with the FDA for Ephar.

Pre-market Notification Details

Device IDK843214
510k NumberK843214
Device Name:EPHAR
ClassificationSystem, Alarm, Electrosurgical
Applicant AKRON CITY HOSPITAL 525 E. MARKET ST. Akron,  OH  44309
ContactTimothy A Bodner
CorrespondentTimothy A Bodner
AKRON CITY HOSPITAL 525 E. MARKET ST. Akron,  OH  44309
Product CodeFFI  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-08-15
Decision Date1984-11-29

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