CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE— 510(k) K111614

Name: FDA 510(k) clearance K111614
Creator: U.S. Food and Drug Administration
Published: 2011-09-26

Substantially Equivalent

Ge Healthcare Integrated IT Solutions

FDA 510(k) clearance K111614 for CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE, Substantially Equivalent on 2011-09-26. Applicant: Ge Healthcare Integrated IT Solutions. Device class: 2.

Clearance details

Applicant: Ge Healthcare Integrated IT Solutions
Product code: Code HGM
Device class: Class 2
Regulation: 21 CFR 884.2740
Advisory panel: Obstetrics/Gynecology
Date received: 2011-06-08
Decision date: 2011-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barrington, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K111614

K-number listed on FDA's recall record

Z-0337-2014 — Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept, transfer, display, calculate, store and manage clinical data. System capabilities provide the user with the ability to acquire data from the medical devices and to document, annotate, display, store, print, export and retrieve patient clinical practice information. This product is intended for professional use only.Class II·Terminated·GE Healthcare It·20130311

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111614.

Data sourced from openFDA. This site is unofficial and independent of the FDA.