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FDA 510(k)

REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8

K-Number: K934638 · 1994-05-13

ApplicantKoven Technology, Inc.
Decision Date1994-05-13
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 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 1994-05-13 under 510(k) number K934638. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8?

REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 is a medical device that received FDA 510(k) clearance on 1994-05-13. The listed applicant is Koven Technology, Inc.. The 510(k) number is K934638.

When did REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 receive FDA 510(k) clearance?

REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 received FDA 510(k) clearance on 1994-05-13, under 510(k) number K934638.

Who is the listed applicant for REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8?

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 REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8?

The FDA product code for REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 is JOP.

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Other records listing Koven Technology, Inc. as applicant

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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: JOP)

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.

K242662Falcon/Xpress (Falcon/Xpress)Viasonix , Ltd.K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLCK153762Smartdop XT6Koven Technology, Inc.K131860VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDINGUs Vascular, LLCK111416FALCONViasonix , Ltd.K071730STUDIODOP VICORDERSkidmore Medical, Limited

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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