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510(k) K040605

Device
DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100
Applicant
DYMEDIX, INC.
510(k) number
K040605
Product code
BZQ  
Decision
Substantially Equivalent (SESE)
Decision date
2004-04-26
Date received
2004-03-08
Regulation
868.2375
Classification name
Monitor, Breathing Frequency
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gary Syring
Address
800 Levanger Ln. Stoughton WI US 53589 53589

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BZQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.2025-09-26
K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.2025-08-05
K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC2025-06-27
K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.2025-04-09
K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.2025-04-04
K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.2025-03-28
K242798AirmodHeroic Faith International , Ltd.2025-02-28
K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.2024-09-11
K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.2023-03-08
K221555Dozee VSTurtle Shell Technologies Private Limited2022-12-15
K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration2022-11-18
K220111RespiraSensePmd Solutions2022-10-07
K211387Breathe Easy Mobile Respiratory Monitor (MRM)Sound Life Sciences, Inc.2021-11-23
K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor ActivationHill-Rom, Inc.2021-03-04
K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.2020-06-24

Legacy Summary#

summary

FDA Review#

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