Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Amc Health. It received FDA 510(k) clearance on 2016-09-09 under 510(k) 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. The listed applicant is Amc Health. The 510(k) number is K151839.

When did AMC Health VitalCaregiving System receive FDA 510(k) clearance?

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

Who is the listed applicant for AMC Health VitalCaregiving System?

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

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

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

Other records listing Amc Health 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.

K233446AMC Health CareConsole

Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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.

↑