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FDA 510(k)

MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM

K-Number: K861544 · 1986-07-18

ApplicantHewlett-Packard Co.
Decision Date1986-07-18
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hewlett-Packard Co.. It received FDA 510(k) clearance on 1986-07-18 under 510(k) number K861544. 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 MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM?

MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1986-07-18. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K861544.

When did MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM receive FDA 510(k) clearance?

MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM received FDA 510(k) clearance on 1986-07-18, under 510(k) number K861544.

Who is the listed applicant for MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM?

The FDA 510(k) record lists Hewlett-Packard Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM?

The FDA product code for MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM is HGM.

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Other records listing Hewlett-Packard Co. 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.

K992543HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLEK993587HP M2376A DEVICE LINK SYSTEMK993169MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810AK992977HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504AK993516HP M2600A VIRIDIA TELEMETRY SYSTEMK993171HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A

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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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