POST-AURICULAR HEARING AID MODEL PE 600PPCL

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 Post-auricular Hearing Aid Model Pe 600ppcl.

Pre-market Notification Details

Device IDK844861
510k NumberK844861
Device Name:POST-AURICULAR HEARING AID MODEL PE 600PPCL
ClassificationHearing Aid, Air Conduction
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 CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-14
Decision Date1985-03-27

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