TD Clip

Device, Anti-snoring

Zephyr Sleep Technologies, Inc.

The following data is part of a premarket notification filed by Zephyr Sleep Technologies, Inc. with the FDA for Td Clip.

Pre-market Notification Details

Device IDK190051
510k NumberK190051
Device Name:TD Clip
ClassificationDevice, Anti-snoring
Applicant Zephyr Sleep Technologies, Inc. 102, 701 64 Ave SE Calgary,  CA T2h 2c3
ContactSabina Bruehlmann
CorrespondentSabina Bruehlmann
Zephyr Sleep Technologies, Inc. 102, 701 64 Ave SE Calgary,  CA T2h 2c3
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-11
Decision Date2019-06-07

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