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)

CAPNOSTREAM20P WITH AI/ODI

K-Number: K112368 · 2012-07-19

ApplicantOridion Medical 1987 , Ltd.
Decision Date2012-07-19
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CAPNOSTREAM20P WITH AI/ODI is the device name listed in this FDA 510(k) record. The listed applicant is Oridion Medical 1987 , Ltd.. It received FDA 510(k) clearance on 2012-07-19 under 510(k) number K112368. 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 CAPNOSTREAM20P WITH AI/ODI?

CAPNOSTREAM20P WITH AI/ODI is a medical device that received FDA 510(k) clearance on 2012-07-19. The listed applicant is Oridion Medical 1987 , Ltd.. The 510(k) number is K112368.

When did CAPNOSTREAM20P WITH AI/ODI receive FDA 510(k) clearance?

CAPNOSTREAM20P WITH AI/ODI received FDA 510(k) clearance on 2012-07-19, under 510(k) number K112368.

Who is the listed applicant for CAPNOSTREAM20P WITH AI/ODI?

The FDA 510(k) record lists Oridion Medical 1987 , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPNOSTREAM20P WITH AI/ODI?

The FDA product code for CAPNOSTREAM20P WITH AI/ODI 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 Oridion Medical 1987 , Ltd. 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.

K200594Capnostream 35 Portable Respiratory MonitorK181624Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling LineK181467Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter LineK121927MICROSTREAM FILTERLINE ICUK093388SMART CAPNOLINE GUARDIANK042665SMART BITEBLOC

View all 17 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.

↑