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FDA 510(k)

PhySoftAMS®

K-Number: K232283 · 2023-12-14

ApplicantPhysician Software Systems, LLC
Decision Date2023-12-14
Product CodeMQS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PhySoftAMS® is the device name listed in this FDA 510(k) record. The listed applicant is Physician Software Systems, LLC. It received FDA 510(k) clearance on 2023-12-14 under 510(k) number K232283. The device is classified under product code MQS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PhySoftAMS®?

PhySoftAMS® is a medical device that received FDA 510(k) clearance on 2023-12-14. The listed applicant is Physician Software Systems, LLC. The 510(k) number is K232283.

When did PhySoftAMS® receive FDA 510(k) clearance?

PhySoftAMS® received FDA 510(k) clearance on 2023-12-14, under 510(k) number K232283.

Who is the listed applicant for PhySoftAMS®?

The FDA 510(k) record lists Physician Software Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PhySoftAMS®?

The FDA product code for PhySoftAMS® is MQS.

Related Devices (Code: MQS)

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.

K180410Dosis SAMDosis, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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