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FDA 510(k)

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)

K-Number: K243216 · 2024-12-10

ApplicantAnalog Devices
Decision Date2024-12-10
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) is a medical device manufactured by Analog Devices. It received FDA 510(k) clearance on 2024-12-10 under approval number K243216. 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 Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)?

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) is a medical device that received FDA 510(k) clearance on 2024-12-10. It is manufactured by Analog Devices. The 510(k) number is K243216.

When was Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) approved by the FDA?

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) received FDA 510(k) clearance on 2024-12-10, under approval number K243216.

What company makes Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)?

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) is manufactured by Analog Devices.

What is the FDA product code for Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)?

The FDA product code for Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) is MWI.

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40246726 [Brief Discussion on the General Requirements of Quality Management System of Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 40061911 Engineering a Quality Management System for Academic Research: Navigating Challenges to Comply with the New Medical Device Regulations in Europe. Medical devices (Auckland, N.Z.) (2025)

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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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