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)

TWINGUARD WITH CAPNOGRAPH ACCESSORY

K-Number: K080527 · 2008-10-31

ApplicantTrawax Pty Limited
Decision Date2008-10-31
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TWINGUARD WITH CAPNOGRAPH ACCESSORY is the device name listed in this FDA 510(k) record. The listed applicant is Trawax Pty Limited. It received FDA 510(k) clearance on 2008-10-31 under 510(k) number K080527. 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 TWINGUARD WITH CAPNOGRAPH ACCESSORY?

TWINGUARD WITH CAPNOGRAPH ACCESSORY is a medical device that received FDA 510(k) clearance on 2008-10-31. The listed applicant is Trawax Pty Limited. The 510(k) number is K080527.

When did TWINGUARD WITH CAPNOGRAPH ACCESSORY receive FDA 510(k) clearance?

TWINGUARD WITH CAPNOGRAPH ACCESSORY received FDA 510(k) clearance on 2008-10-31, under 510(k) number K080527.

Who is the listed applicant for TWINGUARD WITH CAPNOGRAPH ACCESSORY?

The FDA 510(k) record lists Trawax Pty Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TWINGUARD WITH CAPNOGRAPH ACCESSORY?

The FDA product code for TWINGUARD WITH CAPNOGRAPH ACCESSORY 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

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.

↑