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FDA 510(k)

CERNER FETALINK (VERSION 1.0)

K-Number: K091251 · 2009-08-25

ApplicantCerner Corp.
Decision Date2009-08-25
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CERNER FETALINK (VERSION 1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Cerner Corp.. It received FDA 510(k) clearance on 2009-08-25 under 510(k) number K091251. 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 CERNER FETALINK (VERSION 1.0)?

CERNER FETALINK (VERSION 1.0) is a medical device that received FDA 510(k) clearance on 2009-08-25. The listed applicant is Cerner Corp.. The 510(k) number is K091251.

When did CERNER FETALINK (VERSION 1.0) receive FDA 510(k) clearance?

CERNER FETALINK (VERSION 1.0) received FDA 510(k) clearance on 2009-08-25, under 510(k) number K091251.

Who is the listed applicant for CERNER FETALINK (VERSION 1.0)?

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

What is the FDA product code for CERNER FETALINK (VERSION 1.0)?

The FDA product code for CERNER FETALINK (VERSION 1.0) is HGM.

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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 Cerner Corp. 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.

K121758CERNER FETALINK+(VERSION1.0)K093134CERNER CAREAWARE IBUSK091032CERNER PROVISION WORKSTATION (VERSION 2.5)K070394CERNER PROVISION WORKSTATIONK000770PROVIEW MEDICAL IMAGE DISPLAY MODULEK955000REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE

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Related Devices (Code: HGM)

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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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