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)

PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE

K-Number: K912816 · 1992-04-10

ApplicantS & W Medico Teknik
Decision Date1992-04-10
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE 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 1992-04-10 under 510(k) number K912816. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE?

PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE is a medical device that received FDA 510(k) clearance on 1992-04-10. The listed applicant is S & W Medico Teknik. The 510(k) number is K912816.

When did PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE receive FDA 510(k) clearance?

PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE received FDA 510(k) clearance on 1992-04-10, under 510(k) number K912816.

Who is the listed applicant for PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE?

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 PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE?

The FDA product code for PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE is DSK.

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: DSK)

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.

K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLCK160945Endophys Blood Pressure MonitorEndophys Holdings, LLCK080670MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor MedicalK070795SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical Pty, Ltd.K033738MONITORING SYSTEM, MODEL ARGUS PB-2200Schiller AGK021517ABP FOR WINDOWSRozinn Electronics, 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.

↑