Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CAPNOCHECK PLUS

K-Number: K970209 · 1997-04-18

ApplicantBci Intl., Inc.
Decision Date1997-04-18
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CAPNOCHECK PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Bci Intl., Inc.. It received FDA 510(k) clearance on 1997-04-18 under 510(k) number K970209. 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 PLUS?

CAPNOCHECK PLUS is a medical device that received FDA 510(k) clearance on 1997-04-18. The listed applicant is Bci Intl., Inc.. The 510(k) number is K970209.

When did CAPNOCHECK PLUS receive FDA 510(k) clearance?

CAPNOCHECK PLUS received FDA 510(k) clearance on 1997-04-18, under 510(k) number K970209.

Who is the listed applicant for CAPNOCHECK PLUS?

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

What is the FDA product code for CAPNOCHECK PLUS?

The FDA product code for CAPNOCHECK PLUS is CCK.

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 Bci Intl., 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.

K9914103402 HANDHELD PULSE OXIMETERK991086CAPNOCHECK II, MODEL 8400K984618BCI MINI-TORR PLUS, MODEL 6004K9837966004 NIBP MONITOR WITH TEMPERATUREK982279VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200K981939AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR

View all 20 devices →

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.

↑