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FDA 510(k)

DELTEX MEDICAL CARDIOQ-EDM+

K-Number: K132139 · 2013-10-10

ApplicantDeltex Medical Limited
Decision Date2013-10-10
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DELTEX MEDICAL CARDIOQ-EDM+ is the device name listed in this FDA 510(k) record. The listed applicant is Deltex Medical Limited. It received FDA 510(k) clearance on 2013-10-10 under 510(k) number K132139. 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 DELTEX MEDICAL CARDIOQ-EDM+?

DELTEX MEDICAL CARDIOQ-EDM+ is a medical device that received FDA 510(k) clearance on 2013-10-10. The listed applicant is Deltex Medical Limited. The 510(k) number is K132139.

When did DELTEX MEDICAL CARDIOQ-EDM+ receive FDA 510(k) clearance?

DELTEX MEDICAL CARDIOQ-EDM+ received FDA 510(k) clearance on 2013-10-10, under 510(k) number K132139.

Who is the listed applicant for DELTEX MEDICAL CARDIOQ-EDM+?

The FDA 510(k) record lists Deltex Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DELTEX MEDICAL CARDIOQ-EDM+?

The FDA product code for DELTEX MEDICAL CARDIOQ-EDM+ is DPW.

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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Other records listing Deltex Medical Limited 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.

K172457Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMK111542DELTEX MEDICAL CARDIOQ EDMK073593I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016

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

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