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)

CYNERGY MODEL 184

K-Number: K801596 · 1980-09-16

ApplicantCynergy
Decision Date1980-09-16
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CYNERGY MODEL 184 is the device name listed in this FDA 510(k) record. The listed applicant is Cynergy. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801596. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYNERGY MODEL 184?

CYNERGY MODEL 184 is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Cynergy. The 510(k) number is K801596.

When did CYNERGY MODEL 184 receive FDA 510(k) clearance?

CYNERGY MODEL 184 received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801596.

Who is the listed applicant for CYNERGY MODEL 184?

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

What is the FDA product code for CYNERGY MODEL 184?

The FDA product code for CYNERGY MODEL 184 is DTE.

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 Cynergy 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.

K810566SIEMENS MODEL 146-146A EXTERNAL PULSE GK792536CYNERGY MODEL 182K792223PACESETTER MODEL 350K781407ERM-101

Related Devices (Code: DTE)

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.

K241781Solo Pace ControlSolo Pace, Inc.K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, 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.

↑