Solo, Swing Maxi
K-Number: K210759 · 2021-08-11
ApplicantMedela, LLC
Decision Date2021-08-11
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Solo, Swing Maxi is a medical device manufactured by Medela, LLC. It received FDA 510(k) clearance on 2021-08-11 under approval number K210759. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Solo, Swing Maxi?
Solo, Swing Maxi is a medical device that received FDA 510(k) clearance on 2021-08-11. It is manufactured by Medela, LLC. The 510(k) number is K210759.
When was Solo, Swing Maxi approved by the FDA?
Solo, Swing Maxi received FDA 510(k) clearance on 2021-08-11, under approval number K210759.
What company makes Solo, Swing Maxi?
Solo, Swing Maxi is manufactured by Medela, LLC.
What is the FDA product code for Solo, Swing Maxi?
The FDA product code for Solo, Swing Maxi is HGX.
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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.