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FDA 510(k)

EPCOM EMS-330 FREEDOM I TELEDOP OBSTET

K-Number: K831114 · 1983-08-12

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

Device Summary

EPCOM EMS-330 FREEDOM I TELEDOP OBSTET 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 K831114. 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-330 FREEDOM I TELEDOP OBSTET?

EPCOM EMS-330 FREEDOM I TELEDOP OBSTET 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 K831114.

When did EPCOM EMS-330 FREEDOM I TELEDOP OBSTET receive FDA 510(k) clearance?

EPCOM EMS-330 FREEDOM I TELEDOP OBSTET received FDA 510(k) clearance on 1983-08-12, under 510(k) number K831114.

Who is the listed applicant for EPCOM EMS-330 FREEDOM I TELEDOP OBSTET?

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-330 FREEDOM I TELEDOP OBSTET?

The FDA product code for EPCOM EMS-330 FREEDOM I TELEDOP OBSTET 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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