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FDA 510(k)

TUBING BLOOD FLOW METER MODEL NUMBER HD-800

K-Number: K982986 · 1998-11-24

Decision Date1998-11-24
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TUBING BLOOD FLOW METER MODEL NUMBER HD-800 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 1998-11-24 under 510(k) number K982986. 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 TUBING BLOOD FLOW METER MODEL NUMBER HD-800?

TUBING BLOOD FLOW METER MODEL NUMBER HD-800 is a medical device that received FDA 510(k) clearance on 1998-11-24. The listed applicant is Koven Technology, Inc.. The 510(k) number is K982986.

When did TUBING BLOOD FLOW METER MODEL NUMBER HD-800 receive FDA 510(k) clearance?

TUBING BLOOD FLOW METER MODEL NUMBER HD-800 received FDA 510(k) clearance on 1998-11-24, under 510(k) number K982986.

Who is the listed applicant for TUBING BLOOD FLOW METER MODEL NUMBER HD-800?

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 TUBING BLOOD FLOW METER MODEL NUMBER HD-800?

The FDA product code for TUBING BLOOD FLOW METER MODEL NUMBER HD-800 is DPW.

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.

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.

View all 16 devices →

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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