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FDA 510(k)

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15

K-Number: K221879 · 2022-08-10

ApplicantCaf Medical Solutions, Inc.
Decision Date2022-08-10
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 is a medical device manufactured by Caf Medical Solutions, Inc.. It received FDA 510(k) clearance on 2022-08-10 under approval number K221879. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Patient Monitor, models LM-8, LM-10, LM-12 and LM-15?

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 is a medical device that received FDA 510(k) clearance on 2022-08-10. It is manufactured by Caf Medical Solutions, Inc.. The 510(k) number is K221879.

When was Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 approved by the FDA?

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 received FDA 510(k) clearance on 2022-08-10, under approval number K221879.

What company makes Patient Monitor, models LM-8, LM-10, LM-12 and LM-15?

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 is manufactured by Caf Medical Solutions, Inc..

What is the FDA product code for Patient Monitor, models LM-8, LM-10, LM-12 and LM-15?

The FDA product code for Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 is MHX.

Related Clinical Trials

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Related PubMed Literature

PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026) PMID: 41810241 Diverging regulatory DNA in adaptive medical AI: US agility and EU accountability in lifecycle governance. Frontiers in medicine (2026) PMID: 41265798 Comparison of two models of biofilm formation on reusable stainless steel medical device material. The Journal of hospital infection (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Caf Medical Solutions, Inc.

K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 K220362LE-12CH

Related Devices (Code: MHX)

K160981Patient MonitorEdan Instruments, Inc. K153707Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800Philips Medizin Systeme Boeblingen GmbH K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems

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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