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FDA 510(k)

CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE

K-Number: K111614 · 2011-09-26

ApplicantGe Healthcare Integrated IT Solutions
Decision Date2011-09-26
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Integrated IT Solutions. It received FDA 510(k) clearance on 2011-09-26 under 510(k) number K111614. 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 CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE?

CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE is a medical device that received FDA 510(k) clearance on 2011-09-26. The listed applicant is Ge Healthcare Integrated IT Solutions. The 510(k) number is K111614.

When did CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE receive FDA 510(k) clearance?

CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE received FDA 510(k) clearance on 2011-09-26, under 510(k) number K111614.

Who is the listed applicant for CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE?

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

What is the FDA product code for CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE?

The FDA product code for CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE is HGM.

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Other records listing Ge Healthcare Integrated IT Solutions 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.

K121387CENTRICITY PACS-IWK112570CENTRICITY CARDIO IMAGINGK063628CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY

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

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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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