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FDA 510(k)

MODEL HD-207 BIDIRECTIONAL VELOCITY METER

K-Number: K912409 · 1991-12-23

ApplicantKoven and Assoc., Inc.
Decision Date1991-12-23
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL HD-207 BIDIRECTIONAL VELOCITY METER is the device name listed in this FDA 510(k) record. The listed applicant is Koven and Assoc., Inc.. It received FDA 510(k) clearance on 1991-12-23 under 510(k) number K912409. 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 MODEL HD-207 BIDIRECTIONAL VELOCITY METER?

MODEL HD-207 BIDIRECTIONAL VELOCITY METER is a medical device that received FDA 510(k) clearance on 1991-12-23. The listed applicant is Koven and Assoc., Inc.. The 510(k) number is K912409.

When did MODEL HD-207 BIDIRECTIONAL VELOCITY METER receive FDA 510(k) clearance?

MODEL HD-207 BIDIRECTIONAL VELOCITY METER received FDA 510(k) clearance on 1991-12-23, under 510(k) number K912409.

Who is the listed applicant for MODEL HD-207 BIDIRECTIONAL VELOCITY METER?

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

What is the FDA product code for MODEL HD-207 BIDIRECTIONAL VELOCITY METER?

The FDA product code for MODEL HD-207 BIDIRECTIONAL VELOCITY METER is JOP.

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Other records listing Koven and Assoc., Inc. as applicant

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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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