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FDA 510(k)

PhySoftAMS®

K-Number: K232283 · 2023-12-14

Decision Date2023-12-14
Product CodeMQS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PhySoftAMS® is a medical device manufactured by Physician Software Systems, LLC. It received FDA 510(k) clearance on 2023-12-14 under approval 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. It is manufactured by Physician Software Systems, LLC. The 510(k) number is K232283.

When was PhySoftAMS® approved by the FDA?

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

What company makes PhySoftAMS®?

PhySoftAMS® is manufactured by Physician Software Systems, LLC.

What is the FDA product code for PhySoftAMS®?

The FDA product code for PhySoftAMS® is MQS.

Related Devices (Code: MQS)

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.