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 PDU/CDU 9040 (SYSTEM ATHENA)

K-Number: K894700 · 1989-10-02

ApplicantS & W Medico Teknik
Decision Date1989-10-02
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TYPE PDU/CDU 9040 (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 1989-10-02 under 510(k) number K894700. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYPE PDU/CDU 9040 (SYSTEM ATHENA)?

TYPE PDU/CDU 9040 (SYSTEM ATHENA) is a medical device that received FDA 510(k) clearance on 1989-10-02. The listed applicant is S & W Medico Teknik. The 510(k) number is K894700.

When did TYPE PDU/CDU 9040 (SYSTEM ATHENA) receive FDA 510(k) clearance?

TYPE PDU/CDU 9040 (SYSTEM ATHENA) received FDA 510(k) clearance on 1989-10-02, under 510(k) number K894700.

Who is the listed applicant for TYPE PDU/CDU 9040 (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 TYPE PDU/CDU 9040 (SYSTEM ATHENA)?

The FDA product code for TYPE PDU/CDU 9040 (SYSTEM ATHENA) is DRT.

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: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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.

↑