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FDA 510(k)

EPCOM EMS SCAN II

K-Number: K813275 · 1982-03-31

ApplicantEpcom Medical Systems, Inc.
Decision Date1982-03-31
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EPCOM EMS SCAN II 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 1982-03-31 under 510(k) number K813275. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPCOM EMS SCAN II?

EPCOM EMS SCAN II is a medical device that received FDA 510(k) clearance on 1982-03-31. The listed applicant is Epcom Medical Systems, Inc.. The 510(k) number is K813275.

When did EPCOM EMS SCAN II receive FDA 510(k) clearance?

EPCOM EMS SCAN II received FDA 510(k) clearance on 1982-03-31, under 510(k) number K813275.

Who is the listed applicant for EPCOM EMS SCAN II?

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 SCAN II?

The FDA product code for EPCOM EMS SCAN II is IYO.

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Other records listing Epcom Medical Systems, Inc. as applicant

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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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