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FDA 510(k)

PW DOPPLER VASCULAR PROBES

K-Number: K935994 · 1995-05-11

ApplicantKoven Technology, Inc.
Decision Date1995-05-11
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PW DOPPLER VASCULAR PROBES 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 1995-05-11 under 510(k) number K935994. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PW DOPPLER VASCULAR PROBES?

PW DOPPLER VASCULAR PROBES is a medical device that received FDA 510(k) clearance on 1995-05-11. The listed applicant is Koven Technology, Inc.. The 510(k) number is K935994.

When did PW DOPPLER VASCULAR PROBES receive FDA 510(k) clearance?

PW DOPPLER VASCULAR PROBES received FDA 510(k) clearance on 1995-05-11, under 510(k) number K935994.

Who is the listed applicant for PW DOPPLER VASCULAR PROBES?

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 PW DOPPLER VASCULAR PROBES?

The FDA product code for PW DOPPLER VASCULAR PROBES is ITX.

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Other records listing Koven Technology, 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.

K201114Bidop 7K153762Smartdop XT6K080178VALVULOTOME BY KOVENK050601SMARTDOP 45 VASCULAR DOPPLERK031931ECHO SOUNDER EX-101EX 8 MHZK031504ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX

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Related Devices (Code: ITX)

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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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