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FDA 510(k)

MODIFICATION TO CAREMATIX WELLNESS SYSTEM

K-Number: K040966 · 2004-06-02

ApplicantCarematix, Inc.
Decision Date2004-06-02
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO CAREMATIX WELLNESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Carematix, Inc.. It received FDA 510(k) clearance on 2004-06-02 under 510(k) number K040966. 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 MODIFICATION TO CAREMATIX WELLNESS SYSTEM?

MODIFICATION TO CAREMATIX WELLNESS SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-02. The listed applicant is Carematix, Inc.. The 510(k) number is K040966.

When did MODIFICATION TO CAREMATIX WELLNESS SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO CAREMATIX WELLNESS SYSTEM received FDA 510(k) clearance on 2004-06-02, under 510(k) number K040966.

Who is the listed applicant for MODIFICATION TO CAREMATIX WELLNESS SYSTEM?

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 MODIFICATION TO CAREMATIX WELLNESS SYSTEM?

The FDA product code for MODIFICATION TO CAREMATIX WELLNESS SYSTEM 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.

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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-BK073038CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-BK031840CAREMATIX 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

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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