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FDA 510(k)

MODEL KM-25

K-Number: K951449 · 1996-05-20

ApplicantKoven Technology, Inc.
Decision Date1996-05-20
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL KM-25 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 1996-05-20 under 510(k) number K951449. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL KM-25?

MODEL KM-25 is a medical device that received FDA 510(k) clearance on 1996-05-20. The listed applicant is Koven Technology, Inc.. The 510(k) number is K951449.

When did MODEL KM-25 receive FDA 510(k) clearance?

MODEL KM-25 received FDA 510(k) clearance on 1996-05-20, under 510(k) number K951449.

Who is the listed applicant for MODEL KM-25?

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 MODEL KM-25?

The FDA product code for MODEL KM-25 is IYO.

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 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: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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