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FDA 510(k)

MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM

K-Number: K014094 · 2002-01-11

ApplicantHill-Rom Manufacturing, Inc.
Decision Date2002-01-11
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hill-Rom Manufacturing, Inc.. It received FDA 510(k) clearance on 2002-01-11 under 510(k) number K014094. 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 MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM?

MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2002-01-11. The listed applicant is Hill-Rom Manufacturing, Inc.. The 510(k) number is K014094.

When did MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM received FDA 510(k) clearance on 2002-01-11, under 510(k) number K014094.

Who is the listed applicant for MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM?

The FDA 510(k) record lists Hill-Rom Manufacturing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM?

The FDA product code for MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM is HGM.

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Other records listing Hill-Rom Manufacturing, Inc. 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.

K080226NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912K032772MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEMK031387ISOLETTE INFANT INCUBATOR, MODEL C2000E

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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