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FDA 510(k)

Perifit

K-Number: K221476 · 2023-02-10

ApplicantX6 Innovations
Decision Date2023-02-10
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Perifit is a medical device manufactured by X6 Innovations. It received FDA 510(k) clearance on 2023-02-10 under approval number K221476. 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?

Perifit is a medical device that received FDA 510(k) clearance on 2023-02-10. It is manufactured by X6 Innovations. The 510(k) number is K221476.

When was Perifit approved by the FDA?

Perifit received FDA 510(k) clearance on 2023-02-10, under approval number K221476.

What company makes Perifit?

Perifit is manufactured by X6 Innovations.

What is the FDA product code for Perifit?

The FDA product code for Perifit is HIR.

Other Devices by X6 Innovations

K231780Perifit Care+ K231785Perifit Pump

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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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