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)

HASSON BUEC-3

K-Number: K820672 · 1982-07-30

ApplicantBivona Medical Technologies
Decision Date1982-07-30
Product CodeHDP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HASSON BUEC-3 is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1982-07-30 under 510(k) number K820672. The device is classified under product code HDP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HASSON BUEC-3?

HASSON BUEC-3 is a medical device that received FDA 510(k) clearance on 1982-07-30. The listed applicant is Bivona Medical Technologies. The 510(k) number is K820672.

When did HASSON BUEC-3 receive FDA 510(k) clearance?

HASSON BUEC-3 received FDA 510(k) clearance on 1982-07-30, under 510(k) number K820672.

Who is the listed applicant for HASSON BUEC-3?

The FDA 510(k) record lists Bivona Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HASSON BUEC-3?

The FDA product code for HASSON BUEC-3 is HDP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bivona Medical Technologies 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.

K952700SUPERSLICKK942025BURGET NASAL STENTK944178BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBESK935053BIVONA NASAL TURBINATE STENTK933398BIVONA ILLUMINATED ENDOTRACHEAL TUBEK931749BIVONA(R) ICU ENDOTRACHEAL TUBE

View all 50 devices →

Related Devices (Code: HDP)

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.

K974801SINGLE CHANNEL BALLOON CANNULAConkin Surgical Instruments , Ltd.K974563COLPO CUP CVC-2000Clinical Innovations, Inc.K882054HYSTERO KITZinnanti Surgical Instruments, 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.

↑