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FDA 510(k)

ACCESS TM

K-Number: K894290 · 1989-09-07

ApplicantDiasonics, Inc.
Decision Date1989-09-07
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCESS TM is the device name listed in this FDA 510(k) record. The listed applicant is Diasonics, Inc.. It received FDA 510(k) clearance on 1989-09-07 under 510(k) number K894290. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS TM?

ACCESS TM is a medical device that received FDA 510(k) clearance on 1989-09-07. The listed applicant is Diasonics, Inc.. The 510(k) number is K894290.

When did ACCESS TM receive FDA 510(k) clearance?

ACCESS TM received FDA 510(k) clearance on 1989-09-07, under 510(k) number K894290.

Who is the listed applicant for ACCESS TM?

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

What is the FDA product code for ACCESS TM?

The FDA product code for ACCESS TM is LNH.

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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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