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FDA 510(k)

DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100

K-Number: K040605 · 2004-04-26

ApplicantDymedix, Inc.
Decision Date2004-04-26
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 is the device name listed in this FDA 510(k) record. The listed applicant is Dymedix, Inc.. It received FDA 510(k) clearance on 2004-04-26 under 510(k) number K040605. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100?

DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 is a medical device that received FDA 510(k) clearance on 2004-04-26. The listed applicant is Dymedix, Inc.. The 510(k) number is K040605.

When did DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 receive FDA 510(k) clearance?

DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 received FDA 510(k) clearance on 2004-04-26, under 510(k) number K040605.

Who is the listed applicant for DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100?

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

What is the FDA product code for DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100?

The FDA product code for DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 is BZQ.

Related Clinical Trials

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Other records listing Dymedix, 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.

K040069DYMEDIX REUSABLE AIRFLOW/SNORE SENSORK020468CHIN ELECTRODEK001030RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S

Related Devices (Code: BZQ)

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.

K253274BedDot (G1)Intelligent Dots, LLCK251326Respiration Rate algorithmEdwards Lifesciences, LLCK250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLCK243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.

Official Source

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