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FDA 510(k)

HEWLETT PACKARD MODEL M1353A FETAL MONITOR

K-Number: K921956 · 1993-09-24

ApplicantHewlett-Packard Co.
Decision Date1993-09-24
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HEWLETT PACKARD MODEL M1353A FETAL MONITOR 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 1993-09-24 under 510(k) number K921956. 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 HEWLETT PACKARD MODEL M1353A FETAL MONITOR?

HEWLETT PACKARD MODEL M1353A FETAL MONITOR is a medical device that received FDA 510(k) clearance on 1993-09-24. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K921956.

When did HEWLETT PACKARD MODEL M1353A FETAL MONITOR receive FDA 510(k) clearance?

HEWLETT PACKARD MODEL M1353A FETAL MONITOR received FDA 510(k) clearance on 1993-09-24, under 510(k) number K921956.

Who is the listed applicant for HEWLETT PACKARD MODEL M1353A FETAL MONITOR?

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 HEWLETT PACKARD MODEL M1353A FETAL MONITOR?

The FDA product code for HEWLETT PACKARD MODEL M1353A FETAL MONITOR 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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