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)

MAGNO ALARM

K-Number: K960849 · 1997-03-26

ApplicantCardiac Assist Devices, Inc.
Decision Date1997-03-26
Product CodeDTG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAGNO ALARM is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Assist Devices, Inc.. It received FDA 510(k) clearance on 1997-03-26 under 510(k) number K960849. The device is classified under product code DTG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNO ALARM?

MAGNO ALARM is a medical device that received FDA 510(k) clearance on 1997-03-26. The listed applicant is Cardiac Assist Devices, Inc.. The 510(k) number is K960849.

When did MAGNO ALARM receive FDA 510(k) clearance?

MAGNO ALARM received FDA 510(k) clearance on 1997-03-26, under 510(k) number K960849.

Who is the listed applicant for MAGNO ALARM?

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

What is the FDA product code for MAGNO ALARM?

The FDA product code for MAGNO ALARM is DTG.

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 Cardiac Assist Devices, 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.

K012520GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20EK955847GYRO TIP EP CATHETER

Related Devices (Code: DTG)

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.

K092364MODEL 220 PATIENT MAGNETCyberonics, Inc.K895110MAESTRO PACEMAKER TEST MAGNETCardiac Control Systems, Inc.K831926IMPLANTABLE ENDOCARDIAL PACING LEADSOscor, Inc.K813153TEST MAGNETPacesetter Systems

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.

↑