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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtec, Inc. D/B/A Civco Medical Solutions. It received FDA 510(k) clearance on 2016-05-25 under 510(k) 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. The listed applicant is Medtec, Inc. D/B/A Civco Medical Solutions. The 510(k) number is K153026.

When did Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement receive FDA 510(k) clearance?

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 510(k) number K153026.

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

The FDA 510(k) record lists Medtec, Inc. D/B/A Civco Medical Solutions as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07715110Biological Effects of Hemoadsorption in Septic ShockNOT_YET_RECRUITING

Related Devices (Code: IYE)

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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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