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510(k) K240427

airVata™ by Gelb Practice Solutions, Inc. — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2024
Date Received
February 13, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Device, Anti-Snoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

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