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FDA 510(k)

CARDIOSWISS CM-8

K-Number: K910109 · 1991-09-23

ApplicantCare Systems, Inc.
Decision Date1991-09-23
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSWISS CM-8 is the device name listed in this FDA 510(k) record. The listed applicant is Care Systems, Inc.. It received FDA 510(k) clearance on 1991-09-23 under 510(k) number K910109. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOSWISS CM-8?

CARDIOSWISS CM-8 is a medical device that received FDA 510(k) clearance on 1991-09-23. The listed applicant is Care Systems, Inc.. The 510(k) number is K910109.

When did CARDIOSWISS CM-8 receive FDA 510(k) clearance?

CARDIOSWISS CM-8 received FDA 510(k) clearance on 1991-09-23, under 510(k) number K910109.

Who is the listed applicant for CARDIOSWISS CM-8?

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

What is the FDA product code for CARDIOSWISS CM-8?

The FDA product code for CARDIOSWISS CM-8 is DSI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Care Systems, 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.

K894858CARE 5000 SYSTEMK874844CARE TELSTAT MODELS: MP 5010 AND MP 5020

Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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