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FDA 510(k)

BICORE SMARTVALVE OCCLUSION VALVE

K-Number: K921717 · 1992-11-06

ApplicantBicore Monitoring Systems
Decision Date1992-11-06
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BICORE SMARTVALVE OCCLUSION VALVE 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 1992-11-06 under 510(k) number K921717. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BICORE SMARTVALVE OCCLUSION VALVE?

BICORE SMARTVALVE OCCLUSION VALVE is a medical device that received FDA 510(k) clearance on 1992-11-06. The listed applicant is Bicore Monitoring Systems. The 510(k) number is K921717.

When did BICORE SMARTVALVE OCCLUSION VALVE receive FDA 510(k) clearance?

BICORE SMARTVALVE OCCLUSION VALVE received FDA 510(k) clearance on 1992-11-06, under 510(k) number K921717.

Who is the listed applicant for BICORE SMARTVALVE OCCLUSION VALVE?

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 SMARTVALVE OCCLUSION VALVE?

The FDA product code for BICORE SMARTVALVE OCCLUSION VALVE is BZK.

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.

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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 CATHETERK900696BIORE CP-100 CARDIOPULMONARY MONITORK896718BICORE VARIFLEX(R) FLOW TRANSDUCER

Related Devices (Code: BZK)

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.

K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.K192584BEACON Caresystem Model 00002144Mermaid Care A/SK192595ExSpiron 2XiRespiratory MotionK180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K173181ExSpiron 1XiRespiratory Motion, Inc.K162131ExSpiron 1XiRespiratory Motion, 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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