FDA product code MOH: Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use)

MOH is the FDA product code for monitor, heart rate, fetal, non-stress test (home use). It is a Class II device, regulated under 21 CFR 884.2730 and reviewed by the Obstetrics and Gynecology panel. Devices under MOH reach the market by 510(k); FDA lists no cleared 510(k)s for it.

Classification

Recalls for MOH devices

openFDA lists no recalls for product code MOH.

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

• G0399 — Home sleep test (hst) with type iii portable monitor, unattended; minimum of 4 channels: 2 respiratory movement/airflow, 1 ecg/heart rate and 1 oxygen saturation
• G0398 — Home sleep study test (hst) with type ii portable monitor, unattended; minimum of 7 channels: eeg, eog, emg, ecg/heart rate, airflow, respiratory effort and oxygen saturation
• G0400 — Home sleep test (hst) with type iv portable monitor, unattended; minimum of 3 channels

Frequently asked questions

What is FDA product code MOH?

MOH is the FDA product code for monitor, heart rate, fetal, non-stress test (home use). It is a Class II device, regulated under 21 CFR 884.2730 and reviewed by the Obstetrics and Gynecology panel.

What device class is MOH?

Class II, regulation 21 CFR 884.2730. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code MOH
• Run a recall and safety report across every MOH manufacturer
• Watch product code MOH for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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