FDA 510(k)

RAPIDPoint 500e Blood Gas System

K-Number: K192240 · 2020-03-27

ApplicantSiemens Healthcare Diagnostics, Inc.

Decision Date2020-03-27

Product CodeCHL

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

RAPIDPoint 500e Blood Gas System is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-03-27 under approval number K192240. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPIDPoint 500e Blood Gas System?

RAPIDPoint 500e Blood Gas System is a medical device that received FDA 510(k) clearance on 2020-03-27. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K192240.

When was RAPIDPoint 500e Blood Gas System approved by the FDA?

RAPIDPoint 500e Blood Gas System received FDA 510(k) clearance on 2020-03-27, under approval number K192240.

What company makes RAPIDPoint 500e Blood Gas System?

RAPIDPoint 500e Blood Gas System is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for RAPIDPoint 500e Blood Gas System?

The FDA product code for RAPIDPoint 500e Blood Gas System is CHL.

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Related PubMed Literature

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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.