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FDA 510(k)

BIORE CP-100 CARDIOPULMONARY MONITOR

K-Number: K900696 · 1990-11-29

ApplicantBicore Monitoring Systems
Decision Date1990-11-29
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIORE CP-100 CARDIOPULMONARY MONITOR 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 1990-11-29 under 510(k) number K900696. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIORE CP-100 CARDIOPULMONARY MONITOR?

BIORE CP-100 CARDIOPULMONARY MONITOR is a medical device that received FDA 510(k) clearance on 1990-11-29. The listed applicant is Bicore Monitoring Systems. The 510(k) number is K900696.

When did BIORE CP-100 CARDIOPULMONARY MONITOR receive FDA 510(k) clearance?

BIORE CP-100 CARDIOPULMONARY MONITOR received FDA 510(k) clearance on 1990-11-29, under 510(k) number K900696.

Who is the listed applicant for BIORE CP-100 CARDIOPULMONARY MONITOR?

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 BIORE CP-100 CARDIOPULMONARY MONITOR?

The FDA product code for BIORE CP-100 CARDIOPULMONARY MONITOR is BZC.

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 CATHETERK921717BICORE SMARTVALVE OCCLUSION VALVEK896718BICORE VARIFLEX(R) FLOW TRANSDUCER

Related Devices (Code: BZC)

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.

K240293STSTechbopulm, Ltd.K183567Vyntus/SentrySuite Product LineVyaire MedicalK190853Vyntus BODYVyaire Medical, Inc.K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CARTVyaire Medical, Inc.K162515COSMED K5 Wearable Metabolic TechnologyCosmed SrlK161295MiniBox +Pulmone Advanced Medical Devices, Ltd.

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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