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FDA 510(k)

STAT-SAT

K-Number: K874839 · 1988-05-13

ApplicantGish Biomedical, Inc.
Decision Date1988-05-13
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STAT-SAT is the device name listed in this FDA 510(k) record. The listed applicant is Gish Biomedical, Inc.. It received FDA 510(k) clearance on 1988-05-13 under 510(k) number K874839. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT-SAT?

STAT-SAT is a medical device that received FDA 510(k) clearance on 1988-05-13. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K874839.

When did STAT-SAT receive FDA 510(k) clearance?

STAT-SAT received FDA 510(k) clearance on 1988-05-13, under 510(k) number K874839.

Who is the listed applicant for STAT-SAT?

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

What is the FDA product code for STAT-SAT?

The FDA product code for STAT-SAT is DRY.

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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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