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FDA 510(k)

HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)

K-Number: K960817 · 1997-02-11

ApplicantTransonic Systems, Inc.
Decision Date1997-02-11
Product CodeMQS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) is the device name listed in this FDA 510(k) record. The listed applicant is Transonic Systems, Inc.. It received FDA 510(k) clearance on 1997-02-11 under 510(k) number K960817. 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 HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)?

HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) is a medical device that received FDA 510(k) clearance on 1997-02-11. The listed applicant is Transonic Systems, Inc.. The 510(k) number is K960817.

When did HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) receive FDA 510(k) clearance?

HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) received FDA 510(k) clearance on 1997-02-11, under 510(k) number K960817.

Who is the listed applicant for HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)?

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

What is the FDA product code for HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)?

The FDA product code for HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) is MQS.

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Other records listing Transonic Systems, Inc. as applicant

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.

K113821TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEMK112657AUREFLO MONITORING SYSTEMK080116TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEMK033424ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002K022963TRANSONIC SYRINGE WARMER, MODEL SYR-1000K021571TRANSONIC FLOW-QC SET MODEL ADT1010

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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.K130579PHYSOFT AMSPhysicians Software Systems, LLCK042566VASC-ALERTVasc-Alert, Inc.K022963TRANSONIC SYRINGE WARMER, MODEL SYR-1000Transonic Systems, Inc.K021571TRANSONIC FLOW-QC SET MODEL ADT1010Transonic Systems, Inc.

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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