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FDA 510(k)

RAPIDPOINT 500 BLOOD GAS ANALYER

K-Number: K113216 · 2012-05-03

ApplicantSiemens Healthcare Diagnostics
Decision Date2012-05-03
Product CodeKHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAPIDPOINT 500 BLOOD GAS ANALYER is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2012-05-03 under 510(k) number K113216. The device is classified under product code KHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPIDPOINT 500 BLOOD GAS ANALYER?

RAPIDPOINT 500 BLOOD GAS ANALYER is a medical device that received FDA 510(k) clearance on 2012-05-03. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K113216.

When did RAPIDPOINT 500 BLOOD GAS ANALYER receive FDA 510(k) clearance?

RAPIDPOINT 500 BLOOD GAS ANALYER received FDA 510(k) clearance on 2012-05-03, under 510(k) number K113216.

Who is the listed applicant for RAPIDPOINT 500 BLOOD GAS ANALYER?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPIDPOINT 500 BLOOD GAS ANALYER?

The FDA product code for RAPIDPOINT 500 BLOOD GAS ANALYER is KHP.

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Related Devices (Code: KHP)

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.

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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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