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FDA 510(k)

SafeBeat Rx App

K-Number: K251218 · 2026-02-06

ApplicantSafeBeat Rx, Inc.
Decision Date2026-02-06
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SafeBeat Rx App is a medical device manufactured by SafeBeat Rx, Inc.. It received FDA 510(k) clearance on 2026-02-06 under approval number K251218. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SafeBeat Rx App?

SafeBeat Rx App is a medical device that received FDA 510(k) clearance on 2026-02-06. It is manufactured by SafeBeat Rx, Inc.. The 510(k) number is K251218.

When was SafeBeat Rx App approved by the FDA?

SafeBeat Rx App received FDA 510(k) clearance on 2026-02-06, under approval number K251218.

What company makes SafeBeat Rx App?

SafeBeat Rx App is manufactured by SafeBeat Rx, Inc..

What is the FDA product code for SafeBeat Rx App?

The FDA product code for SafeBeat Rx App is DQK.

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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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