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FDA 510(k)

SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR

K-Number: K942613 · 1994-12-23

ApplicantKoven Technology, Inc.
Decision Date1994-12-23
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Koven Technology, Inc.. It received FDA 510(k) clearance on 1994-12-23 under 510(k) number K942613. 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 SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR?

SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR is a medical device that received FDA 510(k) clearance on 1994-12-23. The listed applicant is Koven Technology, Inc.. The 510(k) number is K942613.

When did SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR receive FDA 510(k) clearance?

SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR received FDA 510(k) clearance on 1994-12-23, under 510(k) number K942613.

Who is the listed applicant for SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR?

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

What is the FDA product code for SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR?

The FDA product code for SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR is DPW.

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Other records listing Koven Technology, Inc. as applicant

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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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