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FDA 510(k)

SELF CHECK

K-Number: K791762 · 1979-09-21

ApplicantInstromedix, Inc.
Decision Date1979-09-21
Product CodeDTC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SELF CHECK is the device name listed in this FDA 510(k) record. The listed applicant is Instromedix, Inc.. It received FDA 510(k) clearance on 1979-09-21 under 510(k) number K791762. The device is classified under product code DTC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELF CHECK?

SELF CHECK is a medical device that received FDA 510(k) clearance on 1979-09-21. The listed applicant is Instromedix, Inc.. The 510(k) number is K791762.

When did SELF CHECK receive FDA 510(k) clearance?

SELF CHECK received FDA 510(k) clearance on 1979-09-21, under 510(k) number K791762.

Who is the listed applicant for SELF CHECK?

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

What is the FDA product code for SELF CHECK?

The FDA product code for SELF CHECK is DTC.

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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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