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FDA 510(k)

BabySat 3

K-Number: K222597 · 2023-06-16

ApplicantOwlet Babycare, Inc.
Decision Date2023-06-16
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BabySat 3 is the device name listed in this FDA 510(k) record. The listed applicant is Owlet Babycare, Inc.. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K222597. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BabySat 3?

BabySat 3 is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Owlet Babycare, Inc.. The 510(k) number is K222597.

When did BabySat 3 receive FDA 510(k) clearance?

BabySat 3 received FDA 510(k) clearance on 2023-06-16, under 510(k) number K222597.

Who is the listed applicant for BabySat 3?

The FDA 510(k) record lists Owlet Babycare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BabySat 3?

The FDA product code for BabySat 3 is DQA.

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse 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.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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