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)

MODEL MC6500 ELECTROCARDIOGRAPH

K-Number: K895961 · 1990-01-04

ApplicantCambridge Medical Instruments, Inc.
Decision Date1990-01-04
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL MC6500 ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Medical Instruments, Inc.. It received FDA 510(k) clearance on 1990-01-04 under 510(k) number K895961. 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 MODEL MC6500 ELECTROCARDIOGRAPH?

MODEL MC6500 ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1990-01-04. The listed applicant is Cambridge Medical Instruments, Inc.. The 510(k) number is K895961.

When did MODEL MC6500 ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

MODEL MC6500 ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1990-01-04, under 510(k) number K895961.

Who is the listed applicant for MODEL MC6500 ELECTROCARDIOGRAPH?

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

What is the FDA product code for MODEL MC6500 ELECTROCARDIOGRAPH?

The FDA product code for MODEL MC6500 ELECTROCARDIOGRAPH 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 Cambridge Medical Instruments, 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.

K896771EKG, ECG KENZ, ECG 302K896772EKG, ECG KENZ, ECG 303K883454MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPHK871993MC 6000 MULTI-CHANNEL ELECTROCARDIOGRAPHK862748MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATIONK854282PREVIEW XT

View all 8 devices →

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.

↑