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FDA 510(k)

FILTER PURGE LINE EC-FPL SERIES

K-Number: K833644 · 1984-12-29

ApplicantGish Biomedical, Inc.
Decision Date1984-12-29
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FILTER PURGE LINE EC-FPL SERIES 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 1984-12-29 under 510(k) number K833644. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FILTER PURGE LINE EC-FPL SERIES?

FILTER PURGE LINE EC-FPL SERIES is a medical device that received FDA 510(k) clearance on 1984-12-29. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K833644.

When did FILTER PURGE LINE EC-FPL SERIES receive FDA 510(k) clearance?

FILTER PURGE LINE EC-FPL SERIES received FDA 510(k) clearance on 1984-12-29, under 510(k) number K833644.

Who is the listed applicant for FILTER PURGE LINE EC-FPL SERIES?

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 FILTER PURGE LINE EC-FPL SERIES?

The FDA product code for FILTER PURGE LINE EC-FPL SERIES is DTL.

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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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