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FDA 510(k)

DOPPLEX CENTRALE

K-Number: K060230 · 2006-03-23

ApplicantHuntleigh Healthcare , Ltd.
Decision Date2006-03-23
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DOPPLEX CENTRALE is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare , Ltd.. It received FDA 510(k) clearance on 2006-03-23 under 510(k) number K060230. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOPPLEX CENTRALE?

DOPPLEX CENTRALE is a medical device that received FDA 510(k) clearance on 2006-03-23. The listed applicant is Huntleigh Healthcare , Ltd.. The 510(k) number is K060230.

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

DOPPLEX CENTRALE received FDA 510(k) clearance on 2006-03-23, under 510(k) number K060230.

Who is the listed applicant for DOPPLEX CENTRALE?

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

What is the FDA product code for DOPPLEX CENTRALE?

The FDA product code for DOPPLEX CENTRALE is HGM.

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Other records listing Huntleigh Healthcare , Ltd. 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.

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Related Devices (Code: HGM)

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.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, Inc.

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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