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FDA 510(k)

MECONIUM ASPIRATOR

K-Number: K893649 · 1989-08-21

ApplicantGish Biomedical, Inc.
Decision Date1989-08-21
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MECONIUM ASPIRATOR 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 1989-08-21 under 510(k) number K893649. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MECONIUM ASPIRATOR?

MECONIUM ASPIRATOR is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K893649.

When did MECONIUM ASPIRATOR receive FDA 510(k) clearance?

MECONIUM ASPIRATOR received FDA 510(k) clearance on 1989-08-21, under 510(k) number K893649.

Who is the listed applicant for MECONIUM ASPIRATOR?

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 MECONIUM ASPIRATOR?

The FDA product code for MECONIUM ASPIRATOR is GCX.

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Other records listing Gish Biomedical, Inc. as applicant

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Related Devices (Code: GCX)

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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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