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FDA 510(k)

DOPPLEX ABILITY

K-Number: K121108 · 2013-01-03

ApplicantHuntleigh Healthcare
Decision Date2013-01-03
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DOPPLEX ABILITY is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare. It received FDA 510(k) clearance on 2013-01-03 under 510(k) number K121108. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOPPLEX ABILITY?

DOPPLEX ABILITY is a medical device that received FDA 510(k) clearance on 2013-01-03. The listed applicant is Huntleigh Healthcare. The 510(k) number is K121108.

When did DOPPLEX ABILITY receive FDA 510(k) clearance?

DOPPLEX ABILITY received FDA 510(k) clearance on 2013-01-03, under 510(k) number K121108.

Who is the listed applicant for DOPPLEX ABILITY?

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

What is the FDA product code for DOPPLEX ABILITY?

The FDA product code for DOPPLEX ABILITY is JOM.

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 Huntleigh Healthcare 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.

K053369MEDILOG DARWIN HOLTER ANALYSIS

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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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