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)

CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM

K-Number: K981697 · 1998-10-14

ApplicantCambridge Heart, Inc.
Decision Date1998-10-14
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Heart, Inc.. It received FDA 510(k) clearance on 1998-10-14 under 510(k) number K981697. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM?

CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1998-10-14. The listed applicant is Cambridge Heart, Inc.. The 510(k) number is K981697.

When did CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM received FDA 510(k) clearance on 1998-10-14, under 510(k) number K981697.

Who is the listed applicant for CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM?

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

What is the FDA product code for CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM?

The FDA product code for CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM is DPS.

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 Heart, 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.

K100362CAMBRIDGE HEART OEMK050225HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEMK022152HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APSK022149CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000K013565CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000K013564MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS

View all 17 devices →

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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.

↑