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FDA 510(k)

MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT

K-Number: K090449 · 2009-09-18

ApplicantGish Biomedical, Inc.
Decision Date2009-09-18
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT 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 2009-09-18 under 510(k) number K090449. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT?

MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT is a medical device that received FDA 510(k) clearance on 2009-09-18. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K090449.

When did MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT receive FDA 510(k) clearance?

MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT received FDA 510(k) clearance on 2009-09-18, under 510(k) number K090449.

Who is the listed applicant for MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT?

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 INFANT OXYGENATOR, MODEL 1000, 800 LT?

The FDA product code for MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT is DTZ.

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Other records listing Gish Biomedical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K090450MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LTK091062MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730K083131MEDOS HILITE RESERVOIR, MODEL: 4030K082403MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LTK082082GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATINGK081947GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING

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Related Devices (Code: DTZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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