HEARING AID-MODEL PE-1

Hearing Aid, Air Conduction

STARKEY LABORATORIES, INC.

The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Hearing Aid-model Pe-1.

Pre-market Notification Details

Device IDK772101
510k NumberK772101
Device Name:HEARING AID-MODEL PE-1
ClassificationHearing Aid, Air Conduction
Applicant STARKEY LABORATORIES, 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 Received1977-11-07
Decision Date1977-11-21

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