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FDA 510(k)

AMC Health VitalCaregiving System

K-Number: K151839 · 2016-09-09

ApplicantAmc Health
Decision Date2016-09-09
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMC Health VitalCaregiving System is a medical device manufactured by Amc Health. It received FDA 510(k) clearance on 2016-09-09 under approval number K151839. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMC Health VitalCaregiving System?

AMC Health VitalCaregiving System is a medical device that received FDA 510(k) clearance on 2016-09-09. It is manufactured by Amc Health. The 510(k) number is K151839.

When was AMC Health VitalCaregiving System approved by the FDA?

AMC Health VitalCaregiving System received FDA 510(k) clearance on 2016-09-09, under approval number K151839.

What company makes AMC Health VitalCaregiving System?

AMC Health VitalCaregiving System is manufactured by Amc Health.

What is the FDA product code for AMC Health VitalCaregiving System?

The FDA product code for AMC Health VitalCaregiving System is MWI.

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026)

Other Devices by Amc Health

K233446AMC Health CareConsole

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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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