Wee Bell
K-Number: K221356 · 2023-02-02
ApplicantWee Medical
Decision Date2023-02-02
Product CodeHFX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Wee Bell is a medical device manufactured by Wee Medical. It received FDA 510(k) clearance on 2023-02-02 under approval number K221356. The device is classified under product code HFX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Wee Bell?
Wee Bell is a medical device that received FDA 510(k) clearance on 2023-02-02. It is manufactured by Wee Medical. The 510(k) number is K221356.
When was Wee Bell approved by the FDA?
Wee Bell received FDA 510(k) clearance on 2023-02-02, under approval number K221356.
What company makes Wee Bell?
Wee Bell is manufactured by Wee Medical.
What is the FDA product code for Wee Bell?
The FDA product code for Wee Bell is HFX.
Related Devices (Code: HFX)
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.