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FDA 510(k)

BICORE SMARTCATH INTRATRACHEAL CATHETER

K-Number: K935788 · 1995-07-03

ApplicantBicore Monitoring Systems
Decision Date1995-07-03
Product CodeMOD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BICORE SMARTCATH INTRATRACHEAL CATHETER 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 1995-07-03 under 510(k) number K935788. The device is classified under product code MOD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BICORE SMARTCATH INTRATRACHEAL CATHETER?

BICORE SMARTCATH INTRATRACHEAL CATHETER is a medical device that received FDA 510(k) clearance on 1995-07-03. The listed applicant is Bicore Monitoring Systems. The 510(k) number is K935788.

When did BICORE SMARTCATH INTRATRACHEAL CATHETER receive FDA 510(k) clearance?

BICORE SMARTCATH INTRATRACHEAL CATHETER received FDA 510(k) clearance on 1995-07-03, under 510(k) number K935788.

Who is the listed applicant for BICORE SMARTCATH INTRATRACHEAL CATHETER?

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 SMARTCATH INTRATRACHEAL CATHETER?

The FDA product code for BICORE SMARTCATH INTRATRACHEAL CATHETER is MOD.

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.

K921717BICORE SMARTVALVE OCCLUSION VALVEK900696BIORE CP-100 CARDIOPULMONARY MONITORK896718BICORE VARIFLEX(R) FLOW TRANSDUCER

Related Devices (Code: MOD)

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.

K261360EasyCare Tx 2Resmed CorpK253807Valence InVent Xtend™ (CVG-4101-VXA)Convergence Medical Sciences , Ltd.K260051CorVision® (91-205-Z0014)CorVent® Medical, Inc.K242485EveryWareBreas Medical ABK161411Care Cycle Connect ApplicationRespironics, Inc.K091461BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUECardiopulmonary Corp.

Official Source

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

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