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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 the device name listed in this FDA 510(k) record. The listed applicant is Pixie Cup, LLC. It received FDA 510(k) clearance on 2024-08-12 under 510(k) 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. The listed applicant is Pixie Cup, LLC. The 510(k) number is K241365.

When did Pixie Pulse (SM9068) receive FDA 510(k) clearance?

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

Who is the listed applicant for Pixie Pulse (SM9068)?

The FDA 510(k) record lists Pixie Cup, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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