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FDA 510(k)

EPCOM EMS-310 INTRAPARTUM MONITOR

K-Number: K831113 · 1983-08-12

ApplicantEpcom Medical Systems, Inc.
Decision Date1983-08-12
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EPCOM EMS-310 INTRAPARTUM 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 1983-08-12 under 510(k) number K831113. 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-310 INTRAPARTUM MONITOR?

EPCOM EMS-310 INTRAPARTUM MONITOR is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Epcom Medical Systems, Inc.. The 510(k) number is K831113.

When did EPCOM EMS-310 INTRAPARTUM MONITOR receive FDA 510(k) clearance?

EPCOM EMS-310 INTRAPARTUM MONITOR received FDA 510(k) clearance on 1983-08-12, under 510(k) number K831113.

Who is the listed applicant for EPCOM EMS-310 INTRAPARTUM 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-310 INTRAPARTUM MONITOR?

The FDA product code for EPCOM EMS-310 INTRAPARTUM MONITOR is HGM.

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Other records listing Epcom Medical Systems, Inc. as applicant

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Related Devices (Code: 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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