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FDA 510(k)

AMC Health CareConsole

K-Number: K233446 · 2024-09-27

ApplicantAmc Health
Decision Date2024-09-27
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMC Health CareConsole is the device name listed in this FDA 510(k) record. The listed applicant is Amc Health. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K233446. 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 CareConsole?

AMC Health CareConsole is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Amc Health. The 510(k) number is K233446.

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

AMC Health CareConsole received FDA 510(k) clearance on 2024-09-27, under 510(k) number K233446.

Who is the listed applicant for AMC Health CareConsole?

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 CareConsole?

The FDA product code for AMC Health CareConsole 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.

K151839AMC Health VitalCaregiving System

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.

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