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FDA 510(k)

ABPMpro

K-Number: K231104 · 2023-11-27

ApplicantSomnomedics GmbH
Decision Date2023-11-27
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ABPMpro is a medical device manufactured by Somnomedics GmbH. It received FDA 510(k) clearance on 2023-11-27 under approval number K231104. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABPMpro?

ABPMpro is a medical device that received FDA 510(k) clearance on 2023-11-27. It is manufactured by Somnomedics GmbH. The 510(k) number is K231104.

When was ABPMpro approved by the FDA?

ABPMpro received FDA 510(k) clearance on 2023-11-27, under approval number K231104.

What company makes ABPMpro?

ABPMpro is manufactured by Somnomedics GmbH.

What is the FDA product code for ABPMpro?

The FDA product code for ABPMpro is DSH.

Other Devices by Somnomedics GmbH

K201054SOMNOscreen plus K212325EEG-acp K240700HomeSleepTest (HST, HST REM+)

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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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