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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 a medical device manufactured by Owlet Babycare, Inc.. It received FDA 510(k) clearance on 2023-06-16 under approval 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. It is manufactured by Owlet Babycare, Inc.. The 510(k) number is K222597.

When was BabySat 3 approved by the FDA?

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

What company makes BabySat 3?

BabySat 3 is manufactured by Owlet Babycare, Inc..

What is the FDA product code for BabySat 3?

The FDA product code for BabySat 3 is DQA.

Other Devices by Owlet Babycare, Inc.

DEN220091Dream Sock

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Official Source

View on FDA Database →

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

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