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FDA 510(k)

GUARDIAN, VOLUMETRIC CONTROL DELIVERY

K-Number: K811933 · 1981-07-20

ApplicantAvi, Inc.
Decision Date1981-07-20
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GUARDIAN, VOLUMETRIC CONTROL DELIVERY is the device name listed in this FDA 510(k) record. The listed applicant is Avi, Inc.. It received FDA 510(k) clearance on 1981-07-20 under 510(k) number K811933. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUARDIAN, VOLUMETRIC CONTROL DELIVERY?

GUARDIAN, VOLUMETRIC CONTROL DELIVERY is a medical device that received FDA 510(k) clearance on 1981-07-20. The listed applicant is Avi, Inc.. The 510(k) number is K811933.

When did GUARDIAN, VOLUMETRIC CONTROL DELIVERY receive FDA 510(k) clearance?

GUARDIAN, VOLUMETRIC CONTROL DELIVERY received FDA 510(k) clearance on 1981-07-20, under 510(k) number K811933.

Who is the listed applicant for GUARDIAN, VOLUMETRIC CONTROL DELIVERY?

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

What is the FDA product code for GUARDIAN, VOLUMETRIC CONTROL DELIVERY?

The FDA product code for GUARDIAN, VOLUMETRIC CONTROL DELIVERY is FRN.

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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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