Fociscan Echovisor System

FDA 510(k) K781348 · Metrix Teknika, Inc.

Substantially Equivalent

510(k) numberK781348

Submission

Device name
Fociscan Echovisor System
Applicant
Metrix Teknika, Inc.
Mchenry, IL, US
Received
August 7, 1978
Decision date
October 3, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

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K781803Filter, Eyrpur Disposable LeukociteGKT · Traditional 01/17/1979SE
K781802Washer System, MicroelisaJTC · Traditional 12/20/1978SE
K780035MinivisorHEL · Traditional 03/06/1978SE

Questions and answers

When was Fociscan Echovisor System cleared by the FDA?

Fociscan Echovisor System (K781348) received a 510(k) decision of Substantially Equivalent on October 3, 1978, 57 days after the submission was received.