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FDA 510(k)

PHYSOFT AMS

K-Number: K130579 · 2013-12-19

ApplicantPhysicians Software Systems, LLC
Decision Date2013-12-19
Product CodeMQS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PHYSOFT AMS is the device name listed in this FDA 510(k) record. The listed applicant is Physicians Software Systems, LLC. It received FDA 510(k) clearance on 2013-12-19 under 510(k) number K130579. 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 PHYSOFT AMS?

PHYSOFT AMS is a medical device that received FDA 510(k) clearance on 2013-12-19. The listed applicant is Physicians Software Systems, LLC. The 510(k) number is K130579.

When did PHYSOFT AMS receive FDA 510(k) clearance?

PHYSOFT AMS received FDA 510(k) clearance on 2013-12-19, under 510(k) number K130579.

Who is the listed applicant for PHYSOFT AMS?

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

What is the FDA product code for PHYSOFT AMS?

The FDA product code for PHYSOFT AMS is MQS.

Related Clinical Trials

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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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.

K232283PhySoftAMS®Physician Software Systems, LLCK180410Dosis SAMDosis, Inc.K042566VASC-ALERTVasc-Alert, Inc.K022963TRANSONIC SYRINGE WARMER, MODEL SYR-1000Transonic Systems, Inc.K021571TRANSONIC FLOW-QC SET MODEL ADT1010Transonic Systems, Inc.K001763CRIT-LINE MONITOR III (CLM III)In-Line Diagnostics Corp.

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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