FDA 510(k)

ABPMpro

K-Number: K231104 · 2023-11-27

Decision Date2023-11-27

Product CodeDSH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ABPMpro is the device name listed in this FDA 510(k) record. The listed applicant is Somnomedics GmbH. It received FDA 510(k) clearance on 2023-11-27 under 510(k) 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. The listed applicant is Somnomedics GmbH. The 510(k) number is K231104.

When did ABPMpro receive FDA 510(k) clearance?

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

Who is the listed applicant for ABPMpro?

The FDA 510(k) record lists Somnomedics GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABPMpro?

The FDA product code for ABPMpro is DSH.

Other records listing Somnomedics GmbH as applicant

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.

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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.