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FDA 510(k)

CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B

K-Number: K073038 · 2008-01-11

ApplicantCarematix, Inc.
Decision Date2008-01-11
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B is the device name listed in this FDA 510(k) record. The listed applicant is Carematix, Inc.. It received FDA 510(k) clearance on 2008-01-11 under 510(k) number K073038. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B?

CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B is a medical device that received FDA 510(k) clearance on 2008-01-11. The listed applicant is Carematix, Inc.. The 510(k) number is K073038.

When did CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B receive FDA 510(k) clearance?

CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B received FDA 510(k) clearance on 2008-01-11, under 510(k) number K073038.

Who is the listed applicant for CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B?

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

What is the FDA product code for CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B?

The FDA product code for CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B is DRG.

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 Carematix, 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.

K123020BLIP MODEL BP-700WFK100508CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-BK040966MODIFICATION TO CAREMATIX WELLNESS SYSTEMK031840CAREMATIX WELLNESS SYSTEM

Related Devices (Code: DRG)

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.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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