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FDA 510(k)

V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21

K-Number: K132026 · 2013-12-20

ApplicantMindray DS USA, Inc.
Decision Date2013-12-20
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 is the device name listed in this FDA 510(k) record. The listed applicant is Mindray DS USA, Inc.. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K132026. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21?

V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Mindray DS USA, Inc.. The 510(k) number is K132026.

When did V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 receive FDA 510(k) clearance?

V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 received FDA 510(k) clearance on 2013-12-20, under 510(k) number K132026.

Who is the listed applicant for V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21?

The FDA 510(k) record lists Mindray DS USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21?

The FDA product code for V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 is MHX.

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.

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Other records listing Mindray DS USA, Inc. as applicant

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.

K102471AS3700 ANESTHSIA DELIVERY SYSTEMK102004ENDEAVOUR MONITORING SYSTEM

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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