OWLET BABY CARE

FDA Device Registration & Listing · Lehi, UT, US · Registration 3012977166

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012977166
FEI Number
3012977166
Entity Name
OWLET BABY CARE
City/State/Country
Lehi, UT, US
Establishment Address
2940 West Maple Loop Dr. Suite 203, Lehi, UT 84048, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Owlet Baby Care, Inc. (Owner Number: 10084729)
Owner / Operator Contact Address
2940 West Maple Loop Dr., Suite 203, Lehi, UT 84048, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K222597
PMA Number
N/A

All Registered Proprietary Names

Dream Sock BabySat 3

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QYU Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use Cardiovascular Class 2 870.2705 2023-12-11
DQA Oximeter Cardiovascular Class 2 870.2700 2023-06-29

Official Correspondent

Kristin Young

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Owlet Baby Care, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012977166. Last updated year: 2026. Please use registration number 3012977166 when referencing this establishment in official correspondence.
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