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FDA 510(k)

CAPNOCHECK

K-Number: K941982 · 1994-10-17

ApplicantBci, Inc.
Decision Date1994-10-17
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CAPNOCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Bci, Inc.. It received FDA 510(k) clearance on 1994-10-17 under 510(k) number K941982. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPNOCHECK?

CAPNOCHECK is a medical device that received FDA 510(k) clearance on 1994-10-17. The listed applicant is Bci, Inc.. The 510(k) number is K941982.

When did CAPNOCHECK receive FDA 510(k) clearance?

CAPNOCHECK received FDA 510(k) clearance on 1994-10-17, under 510(k) number K941982.

Who is the listed applicant for CAPNOCHECK?

The FDA 510(k) record lists Bci, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPNOCHECK?

The FDA product code for CAPNOCHECK is CCK.

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Other records listing Bci, Inc. 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.

K030407ADVISOR, MODEL 9200K031742BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETERK020739BCI 3178 PEDIATRIC PULSE OXIMETRY SENSORK020350BCI 3180 PULSE OXIMETERK013862BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAMK0131713420 DIGIT PULSE OXIMETER, MODEL 3420

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Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, 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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