PHONIC EAR MODEL PE 810S

Hearing Aid, Air Conduction

PHONIC EAR, INC.

The following data is part of a premarket notification filed by Phonic Ear, Inc. with the FDA for Phonic Ear Model Pe 810s.

Pre-market Notification Details

Device IDK820172
510k NumberK820172
Device Name:PHONIC EAR MODEL PE 810S
ClassificationHearing Aid, Air Conduction
Applicant PHONIC EAR, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-01-21
Decision Date1982-02-24

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