FDA.report

510(k) K222597

Device
BabySat 3
Applicant
Owlet Babycare, Inc.
510(k) number
K222597
Product code
DQA
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-16
Date received
2022-08-29
Regulation
870.2700
Classification name
Oximeter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Tammy Lavery
Address
3300 Ashton Blvd. Suite 300 Lehi UT US 84043 84043

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00810099090086BabySat Monitoring SystemOwlet Baby Care, Inc.2024-01-08
00810099090079BabySat 3 Rx AppOwlet Baby Care, Inc.2024-01-08
00810099090031BabySat 3 Rx SensorOwlet Baby Care, Inc.2024-01-08
00810099090024 BabySat 3 Rx Base StationOwlet Baby Care, Inc.2024-01-08

Other 510(k) Records For Product Code DQA

510(k)DeviceApplicantDecision date
K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.2026-05-11
K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin Systeme2026-05-01
K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.2026-04-14
K252448AViTA Pulse Oximeter (SP61)Avita Corporation2026-02-27
K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-02-17
K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.2026-01-07
K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.2025-12-19
K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)Unimed Medical Supplies, Inc.2025-12-01
K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)Unimed Medical Supplies, Inc.2025-12-01
K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)Unimed Medical Supplies, Inc.2025-11-18
K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75)Unimed Medical Supplies, Inc.2025-11-18
K250837Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.2025-09-25
K250931Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)Unimed Medical Supplies, Inc.2025-08-13
K241086Avidhrt Sense SpO2Avidhrt, Inc.2025-05-09
K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.2025-02-28