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FDA 510(k)

MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM

K-Number: K942887 · 1994-08-15

ApplicantHewlett-Packard Co.
Decision Date1994-08-15
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL M1310A, SERIES 50T FETAL TELEMETRY 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 1994-08-15 under 510(k) number K942887. 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 M1310A, SERIES 50T FETAL TELEMETRY SYSTEM?

MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 1994-08-15. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K942887.

When did MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM receive FDA 510(k) clearance?

MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM received FDA 510(k) clearance on 1994-08-15, under 510(k) number K942887.

Who is the listed applicant for MODEL M1310A, SERIES 50T FETAL TELEMETRY 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 M1310A, SERIES 50T FETAL TELEMETRY SYSTEM?

The FDA product code for MODEL M1310A, SERIES 50T FETAL TELEMETRY 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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