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)

CARDIOCASSETTE II

K-Number: K772027 · 1977-11-09

ApplicantCardiodyne, Inc.
Decision Date1977-11-09
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOCASSETTE II is the device name listed in this FDA 510(k) record. The listed applicant is Cardiodyne, Inc.. It received FDA 510(k) clearance on 1977-11-09 under 510(k) number K772027. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOCASSETTE II?

CARDIOCASSETTE II is a medical device that received FDA 510(k) clearance on 1977-11-09. The listed applicant is Cardiodyne, Inc.. The 510(k) number is K772027.

When did CARDIOCASSETTE II receive FDA 510(k) clearance?

CARDIOCASSETTE II received FDA 510(k) clearance on 1977-11-09, under 510(k) number K772027.

Who is the listed applicant for CARDIOCASSETTE II?

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

What is the FDA product code for CARDIOCASSETTE II?

The FDA product code for CARDIOCASSETTE II is DSH.

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 Cardiodyne, Inc. 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.

K911871CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORSK781932BLOOD PRESSURE RECORDER

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., 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.

↑