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FDA 510(k)

BICORE VARIFLEX(R) FLOW TRANSDUCER

K-Number: K896718 · 1990-02-22

ApplicantBicore Monitoring Systems
Decision Date1990-02-22
Product CodeBYR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BICORE VARIFLEX(R) FLOW TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Bicore Monitoring Systems. It received FDA 510(k) clearance on 1990-02-22 under 510(k) number K896718. The device is classified under product code BYR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BICORE VARIFLEX(R) FLOW TRANSDUCER?

BICORE VARIFLEX(R) FLOW TRANSDUCER is a medical device that received FDA 510(k) clearance on 1990-02-22. The listed applicant is Bicore Monitoring Systems. The 510(k) number is K896718.

When did BICORE VARIFLEX(R) FLOW TRANSDUCER receive FDA 510(k) clearance?

BICORE VARIFLEX(R) FLOW TRANSDUCER received FDA 510(k) clearance on 1990-02-22, under 510(k) number K896718.

Who is the listed applicant for BICORE VARIFLEX(R) FLOW TRANSDUCER?

The FDA 510(k) record lists Bicore Monitoring Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BICORE VARIFLEX(R) FLOW TRANSDUCER?

The FDA product code for BICORE VARIFLEX(R) FLOW TRANSDUCER is BYR.

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 Bicore Monitoring Systems 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.

K935788BICORE SMARTCATH INTRATRACHEAL CATHETERK921717BICORE SMARTVALVE OCCLUSION VALVEK900696BIORE CP-100 CARDIOPULMONARY MONITOR

Related Devices (Code: BYR)

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.

K801880MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANSMedical Measurements, Inc.K790334DRAGER ORMDraeger Medical, 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.

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