OTOGRAM, CA3350

Audiometer

TYMPANY, INC.

The following data is part of a premarket notification filed by Tympany, Inc. with the FDA for Otogram, Ca3350.

Pre-market Notification Details

Device IDK070118
510k NumberK070118
Device Name:OTOGRAM, CA3350
ClassificationAudiometer
Applicant TYMPANY, INC. 2795 EAST COTTONWOOD PKWY. SUITE 660 Salt Lake City,  UT  84121
ContactLex J Pearce
CorrespondentLex J Pearce
TYMPANY, INC. 2795 EAST COTTONWOOD PKWY. SUITE 660 Salt Lake City,  UT  84121
Product CodeEWO  
Subsequent Product CodeETY
Subsequent Product CodeNAS
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-12
Decision Date2007-03-07
Summary:summary

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