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FDA 510(k)

ACCESS(TM), SOFTWARE RELEASE 4.11P

K-Number: K896637 · 1990-01-22

ApplicantDiasonics, Inc.
Decision Date1990-01-22
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACCESS(TM), SOFTWARE RELEASE 4.11P is the device name listed in this FDA 510(k) record. The listed applicant is Diasonics, Inc.. It received FDA 510(k) clearance on 1990-01-22 under 510(k) number K896637. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS(TM), SOFTWARE RELEASE 4.11P?

ACCESS(TM), SOFTWARE RELEASE 4.11P is a medical device that received FDA 510(k) clearance on 1990-01-22. The listed applicant is Diasonics, Inc.. The 510(k) number is K896637.

When did ACCESS(TM), SOFTWARE RELEASE 4.11P receive FDA 510(k) clearance?

ACCESS(TM), SOFTWARE RELEASE 4.11P received FDA 510(k) clearance on 1990-01-22, under 510(k) number K896637.

Who is the listed applicant for ACCESS(TM), SOFTWARE RELEASE 4.11P?

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), SOFTWARE RELEASE 4.11P?

The FDA product code for ACCESS(TM), SOFTWARE RELEASE 4.11P is LPH.

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Other records listing Diasonics, Inc. as applicant

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Related Devices (Code: LPH)

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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