Perifit Care+
K-Number: K231780 · 2023-12-20
ApplicantX6 Innovations
Decision Date2023-12-20
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Perifit Care+ is a medical device manufactured by X6 Innovations. It received FDA 510(k) clearance on 2023-12-20 under approval number K231780. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Perifit Care+?
Perifit Care+ is a medical device that received FDA 510(k) clearance on 2023-12-20. It is manufactured by X6 Innovations. The 510(k) number is K231780.
When was Perifit Care+ approved by the FDA?
Perifit Care+ received FDA 510(k) clearance on 2023-12-20, under approval number K231780.
What company makes Perifit Care+?
Perifit Care+ is manufactured by X6 Innovations.
What is the FDA product code for Perifit Care+?
The FDA product code for Perifit Care+ is HIR.
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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.