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FDA 510(k)

CPM System

K-Number: K231086 · 2023-12-22

ApplicantAnalog Devices, Inc.
Decision Date2023-12-22
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CPM System is the device name listed in this FDA 510(k) record. The listed applicant is Analog Devices, Inc.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K231086. 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 CPM System?

CPM System is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Analog Devices, Inc.. The 510(k) number is K231086.

When did CPM System receive FDA 510(k) clearance?

CPM System received FDA 510(k) clearance on 2023-12-22, under 510(k) number K231086.

Who is the listed applicant for CPM System?

The FDA 510(k) record lists Analog Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPM System?

The FDA product code for CPM System is MWI.

Other records listing Analog Devices, Inc. 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.

K243216Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)

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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