FDA 510(k)

ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)

K-Number: K936286 · 1994-02-14

Decision Date1994-02-14

Product CodeDTN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER) 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 1994-02-14 under 510(k) number K936286. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)?

ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER) is a medical device that received FDA 510(k) clearance on 1994-02-14. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K936286.

When did ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER) receive FDA 510(k) clearance?

ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER) received FDA 510(k) clearance on 1994-02-14, under 510(k) number K936286.

Who is the listed applicant for ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)?

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 ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)?

The FDA product code for ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER) is DTN.

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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.