PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER

Hearing Aid, Group And Auditory Trainer

PHONIC EAR, INC.

The following data is part of a premarket notification filed by Phonic Ear, Inc. with the FDA for Pe100r Fm Receiver Used W/pe100t Fm Transmitter.

Pre-market Notification Details

Device IDK882409
510k NumberK882409
Device Name:PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER
ClassificationHearing Aid, Group And Auditory Trainer
Applicant PHONIC EAR, INC. 250 CAMINO ALTO Mill Valley,  CA  94941
ContactRobert L Reinke
CorrespondentRobert L Reinke
PHONIC EAR, INC. 250 CAMINO ALTO Mill Valley,  CA  94941
Product CodeEPF  
CFR Regulation Number874.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-10
Decision Date1988-07-05

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