Data / Medical devices / United States / Monovo, LLC

Monovo, LLC: FDA-registered device maker in Alpine, UT, United States, 4 510(k) clearances

Name: Monovo, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Monovo, LLC is registered with the FDA (registration 3021131596) in Alpine, UT, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 28, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3021131596
Address: 375 S Main St Ste 200, Alpine, UT, United States, 84004
Owner or operator: Monovo, LLC (10083664)
Roles: Repackager or relabeler
First device listed: December 9, 2021
Registered through: 2026
Brand names listed: Monovo Air Blood Pressure Monitor, Monovo O2Ring Pulse Oximeter, Monovo Pulse Pulse Oximeter

Devices it lists

Device	Product code	Class	Role	Source
Electrocardiograph	DPS	2	Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 28, 2025	K242876	Pulse Oximeter ( PO2, PO2A, PO2B)	DQA	Substantially Equivalent	Shenzhen Viatom Technology Co., Ltd.	accessdata.fda.gov
June 25, 2020	K193348	Blood Pressure Monitor	DXN	Substantially Equivalent	Shenzhen Viatom Technology Co., Ltd.	accessdata.fda.gov
December 2, 2019	K191088	Checkme O2 Pulse Oximeter	DQA	Substantially Equivalent	Shenzhen Viatom Technology Co., Ltd.	accessdata.fda.gov
August 19, 2019	K190207	Blood Pressure Monitor	DXN	Substantially Equivalent	Shenzhen Viatom Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated February 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.