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FDA 510(k)

Pixie Pulse (SM9068)

K-Number: K241365 · 2024-08-12

ApplicantPixie Cup, LLC
Decision Date2024-08-12
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Pixie Pulse (SM9068) is a medical device manufactured by Pixie Cup, LLC. It received FDA 510(k) clearance on 2024-08-12 under approval number K241365. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pixie Pulse (SM9068)?

Pixie Pulse (SM9068) is a medical device that received FDA 510(k) clearance on 2024-08-12. It is manufactured by Pixie Cup, LLC. The 510(k) number is K241365.

When was Pixie Pulse (SM9068) approved by the FDA?

Pixie Pulse (SM9068) received FDA 510(k) clearance on 2024-08-12, under approval number K241365.

What company makes Pixie Pulse (SM9068)?

Pixie Pulse (SM9068) is manufactured by Pixie Cup, LLC.

What is the FDA product code for Pixie Pulse (SM9068)?

The FDA product code for Pixie Pulse (SM9068) is NUH.

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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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