FDA 510(k)

EMI FOUR

K-Number: K771902 · 1977-10-19

Decision Date1977-10-19

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EMI FOUR is the device name listed in this FDA 510(k) record. The listed applicant is Emi Therapy Systems, Inc.. It received FDA 510(k) clearance on 1977-10-19 under 510(k) number K771902. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMI FOUR?

EMI FOUR is a medical device that received FDA 510(k) clearance on 1977-10-19. The listed applicant is Emi Therapy Systems, Inc.. The 510(k) number is K771902.

When did EMI FOUR receive FDA 510(k) clearance?

EMI FOUR received FDA 510(k) clearance on 1977-10-19, under 510(k) number K771902.

Who is the listed applicant for EMI FOUR?

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

What is the FDA product code for EMI FOUR?

The FDA product code for EMI FOUR is IYE.

Other records listing Emi Therapy Systems, Inc. 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.

K781084THERAPAX 150A K780948SYSTEM, PLANNING, TREATMENT K780027ACCELERATOR, LINEAR, MED.K771817EMI THERAPY SIMULATOR

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.