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FDA 510(k)

AUREFLO MONITORING SYSTEM

K-Number: K112657 · 2011-12-21

ApplicantTransonic Systems, Inc.
Decision Date2011-12-21
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUREFLO MONITORING SYSTEM 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 2011-12-21 under 510(k) number K112657. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUREFLO MONITORING SYSTEM?

AUREFLO MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-21. The listed applicant is Transonic Systems, Inc.. The 510(k) number is K112657.

When did AUREFLO MONITORING SYSTEM receive FDA 510(k) clearance?

AUREFLO MONITORING SYSTEM received FDA 510(k) clearance on 2011-12-21, under 510(k) number K112657.

Who is the listed applicant for AUREFLO MONITORING SYSTEM?

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 AUREFLO MONITORING SYSTEM?

The FDA product code for AUREFLO MONITORING SYSTEM is DPW.

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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 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 ADT1010K010253ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101

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Related Devices (Code: DPW)

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.

K260700BlueDop Vascular ExpertBlueDop Medical, Ltd.K252810FloPatch FP120Flosonics MedicalK251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)Remington Medical, Inc.K251114FloPatch FP120Flosonics MedicalK243852Elfor-LElfi-Tech , Ltd.K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)Remington Medical, 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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