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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K222597
Device Name BabySat 3
Applicant
Owlet Babycare, Inc.
3300 Ashton Blvd. Suite 300
Lehi,  UT  84043
Applicant Contact Tammy Lavery
Correspondent
ProMedic Consulting, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/29/2022
Decision Date 06/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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