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)

TCPO2 9260 MODULE - SYSTEM ATHENA

K-Number: K913013 · 1994-05-03

ApplicantS & W Medico Teknik
Decision Date1994-05-03
Product CodeLKD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TCPO2 9260 MODULE - SYSTEM ATHENA is the device name listed in this FDA 510(k) record. The listed applicant is S & W Medico Teknik. It received FDA 510(k) clearance on 1994-05-03 under 510(k) number K913013. The device is classified under product code LKD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TCPO2 9260 MODULE - SYSTEM ATHENA?

TCPO2 9260 MODULE - SYSTEM ATHENA is a medical device that received FDA 510(k) clearance on 1994-05-03. The listed applicant is S & W Medico Teknik. The 510(k) number is K913013.

When did TCPO2 9260 MODULE - SYSTEM ATHENA receive FDA 510(k) clearance?

TCPO2 9260 MODULE - SYSTEM ATHENA received FDA 510(k) clearance on 1994-05-03, under 510(k) number K913013.

Who is the listed applicant for TCPO2 9260 MODULE - SYSTEM ATHENA?

The FDA 510(k) record lists S & W Medico Teknik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TCPO2 9260 MODULE - SYSTEM ATHENA?

The FDA product code for TCPO2 9260 MODULE - SYSTEM ATHENA is LKD.

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 S & W Medico Teknik 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.

K9409339267 SPO2 ATHENA MODULEK915633MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENAK9301349055 IRCA OPTION FOR SYSTEM ATHENA 9050 NTK9234189293/1 INTERFACE MODULEK911611SYSTEM ATHENA, MODIFICATIONK922314VENTILATOR INTERFACE 9291/4

View all 46 devices →

Related Devices (Code: LKD)

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.

K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AGK131253PERIFLUX 6000Perimed ABK110474PHILIPS INTELLIVUE TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac ANK101690SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLESentec AGK093154TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEMRadiometer Medical ApsK043357TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009Linde Medical Sensors AG

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.

↑