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FDA 510(k)

MEDOS HILITE RESERVOIR, MODEL: 4030

K-Number: K083131 · 2009-07-30

ApplicantGish Biomedical, Inc.
Decision Date2009-07-30
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDOS HILITE RESERVOIR, MODEL: 4030 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 2009-07-30 under 510(k) number K083131. 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 MEDOS HILITE RESERVOIR, MODEL: 4030?

MEDOS HILITE RESERVOIR, MODEL: 4030 is a medical device that received FDA 510(k) clearance on 2009-07-30. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K083131.

When did MEDOS HILITE RESERVOIR, MODEL: 4030 receive FDA 510(k) clearance?

MEDOS HILITE RESERVOIR, MODEL: 4030 received FDA 510(k) clearance on 2009-07-30, under 510(k) number K083131.

Who is the listed applicant for MEDOS HILITE RESERVOIR, MODEL: 4030?

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 MEDOS HILITE RESERVOIR, MODEL: 4030?

The FDA product code for MEDOS HILITE RESERVOIR, MODEL: 4030 is DTN.

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Other records listing Gish Biomedical, Inc. as applicant

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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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