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FDA 510(k)

EDM

K-Number: K951369 · 1995-11-07

ApplicantDeltex Medical
Decision Date1995-11-07
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EDM is the device name listed in this FDA 510(k) record. The listed applicant is Deltex Medical. It received FDA 510(k) clearance on 1995-11-07 under 510(k) number K951369. 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 EDM?

EDM is a medical device that received FDA 510(k) clearance on 1995-11-07. The listed applicant is Deltex Medical. The 510(k) number is K951369.

When did EDM receive FDA 510(k) clearance?

EDM received FDA 510(k) clearance on 1995-11-07, under 510(k) number K951369.

Who is the listed applicant for EDM?

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

What is the FDA product code for EDM?

The FDA product code for EDM is DPW.

Other records listing Deltex Medical 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.

K052989DP240 240 HOUR DOPPLER PROBEK031706CARDIOQ, MODEL 9051-7005

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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