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FDA 510(k)

Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement

K-Number: K153026 · 2016-05-25

ApplicantMedtec, Inc. D/B/A Civco Medical Solutions
Decision Date2016-05-25
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement is a medical device manufactured by Medtec, Inc. D/B/A Civco Medical Solutions. It received FDA 510(k) clearance on 2016-05-25 under approval number K153026. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement?

Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement is a medical device that received FDA 510(k) clearance on 2016-05-25. It is manufactured by Medtec, Inc. D/B/A Civco Medical Solutions. The 510(k) number is K153026.

When was Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement approved by the FDA?

Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement received FDA 510(k) clearance on 2016-05-25, under approval number K153026.

What company makes Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement?

Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement is manufactured by Medtec, Inc. D/B/A Civco Medical Solutions.

What is the FDA product code for Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement?

The FDA product code for Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement is IYE.

Related Clinical Trials

NCT02030691 Tolerance of nHFPV Versus nCPAP in Neonatal Respiratory Distress COMPLETED NCT02389166 Optiflow in Sequential Non-Invasive Ventilation COMPLETED NCT01928238 Physiologic Effects of Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) Versus Noninvasive Pressure Support Ventilation in Patients at Risk for Respiratory Distress Needed Preventive Used of Noninvasive Ventilation After Extubation. COMPLETED NCT07604961 Short-Term Inspiratory Muscle Training and Aerobic Exercise in Women With COPD COMPLETED NCT06990477 Effect of EIT-guided PEEP in ARDS Patients RECRUITING NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING

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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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