Diamond Digital Sleep Orthotic (DDSO)

Device, Anti-snoring

Diamond Orthotic Laboratory

The following data is part of a premarket notification filed by Diamond Orthotic Laboratory with the FDA for Diamond Digital Sleep Orthotic (ddso).

Pre-market Notification Details

Device IDK202499
510k NumberK202499
Device Name:Diamond Digital Sleep Orthotic (DDSO)
ClassificationDevice, Anti-snoring
Applicant Diamond Orthotic Laboratory 7859 El Cajon Blvd. La Mesa,  CA  91942
ContactMatt Rago
CorrespondentDave Yungvurt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-08-31
Decision Date2020-09-03

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