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)

TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)

K-Number: K884120 · 1990-07-17

ApplicantS & W Medico Teknik
Decision Date1990-07-17
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC) 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 1990-07-17 under 510(k) number K884120. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)?

TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC) is a medical device that received FDA 510(k) clearance on 1990-07-17. The listed applicant is S & W Medico Teknik. The 510(k) number is K884120.

When did TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC) receive FDA 510(k) clearance?

TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC) received FDA 510(k) clearance on 1990-07-17, under 510(k) number K884120.

Who is the listed applicant for TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)?

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 TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)?

The FDA product code for TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC) is BZQ.

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 MODULEK913013TCPO2 9260 MODULE - SYSTEM ATHENAK915633MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENAK9301349055 IRCA OPTION FOR SYSTEM ATHENA 9050 NTK9234189293/1 INTERFACE MODULEK911611SYSTEM ATHENA, MODIFICATION

View all 46 devices →

Related Devices (Code: BZQ)

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.

K253274BedDot (G1)Intelligent Dots, LLCK251326Respiration Rate algorithmEdwards Lifesciences, LLCK250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLCK243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.

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.

↑