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FDA 510(k)

GENADYNE A4 POWERED SUCTION PUMP

K-Number: K080745 · 2008-07-30

ApplicantGenadyne Biotechnologies, Inc.
Decision Date2008-07-30
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GENADYNE A4 POWERED SUCTION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Genadyne Biotechnologies, Inc.. It received FDA 510(k) clearance on 2008-07-30 under 510(k) number K080745. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENADYNE A4 POWERED SUCTION PUMP?

GENADYNE A4 POWERED SUCTION PUMP is a medical device that received FDA 510(k) clearance on 2008-07-30. The listed applicant is Genadyne Biotechnologies, Inc.. The 510(k) number is K080745.

When did GENADYNE A4 POWERED SUCTION PUMP receive FDA 510(k) clearance?

GENADYNE A4 POWERED SUCTION PUMP received FDA 510(k) clearance on 2008-07-30, under 510(k) number K080745.

Who is the listed applicant for GENADYNE A4 POWERED SUCTION PUMP?

The FDA 510(k) record lists Genadyne Biotechnologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENADYNE A4 POWERED SUCTION PUMP?

The FDA product code for GENADYNE A4 POWERED SUCTION PUMP is BTA.

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Related Devices (Code: BTA)

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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