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FDA 510(k)

EPCOM EMS-180 ANTEPARTUM FETAL MONITOR

K-Number: K813007 · 1981-12-10

ApplicantEpcom Medical Systems, Inc.
Decision Date1981-12-10
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EPCOM EMS-180 ANTEPARTUM FETAL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Epcom Medical Systems, Inc.. It received FDA 510(k) clearance on 1981-12-10 under 510(k) number K813007. 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 EPCOM EMS-180 ANTEPARTUM FETAL MONITOR?

EPCOM EMS-180 ANTEPARTUM FETAL MONITOR is a medical device that received FDA 510(k) clearance on 1981-12-10. The listed applicant is Epcom Medical Systems, Inc.. The 510(k) number is K813007.

When did EPCOM EMS-180 ANTEPARTUM FETAL MONITOR receive FDA 510(k) clearance?

EPCOM EMS-180 ANTEPARTUM FETAL MONITOR received FDA 510(k) clearance on 1981-12-10, under 510(k) number K813007.

Who is the listed applicant for EPCOM EMS-180 ANTEPARTUM FETAL MONITOR?

The FDA 510(k) record lists Epcom Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPCOM EMS-180 ANTEPARTUM FETAL MONITOR?

The FDA product code for EPCOM EMS-180 ANTEPARTUM FETAL MONITOR is HGM.

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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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