Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM

K-Number: K894892 · 1989-10-27

Decision Date1989-10-27
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM 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 1989-10-27 under 510(k) number K894892. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM?

HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 1989-10-27. The listed applicant is Koven and Assoc., Inc.. The 510(k) number is K894892.

When did HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM receive FDA 510(k) clearance?

HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM received FDA 510(k) clearance on 1989-10-27, under 510(k) number K894892.

Who is the listed applicant for HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM?

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 HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM?

The FDA product code for HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM is DSB.

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 and Assoc., 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 8 devices →

Related Devices (Code: DSB)

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

View on FDA Database →

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

↑