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FDA 510(k)

ENTRUST(TM) MODEL 800

K-Number: K882047 · 1988-08-11

ApplicantAvi, Inc.
Decision Date1988-08-11
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ENTRUST(TM) MODEL 800 is the device name listed in this FDA 510(k) record. The listed applicant is Avi, Inc.. It received FDA 510(k) clearance on 1988-08-11 under 510(k) number K882047. 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 ENTRUST(TM) MODEL 800?

ENTRUST(TM) MODEL 800 is a medical device that received FDA 510(k) clearance on 1988-08-11. The listed applicant is Avi, Inc.. The 510(k) number is K882047.

When did ENTRUST(TM) MODEL 800 receive FDA 510(k) clearance?

ENTRUST(TM) MODEL 800 received FDA 510(k) clearance on 1988-08-11, under 510(k) number K882047.

Who is the listed applicant for ENTRUST(TM) MODEL 800?

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 ENTRUST(TM) MODEL 800?

The FDA product code for ENTRUST(TM) MODEL 800 is FRN.

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Other records listing Avi, Inc. as applicant

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Related Devices (Code: 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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