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)

ECLIPSE 4 ELECTROCARDIOGRAPH

K-Number: K943959 · 1995-05-17

ApplicantBurdick, Inc.
Decision Date1995-05-17
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

ECLIPSE 4 ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Burdick, Inc.. It received FDA 510(k) clearance on 1995-05-17 under 510(k) number K943959. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECLIPSE 4 ELECTROCARDIOGRAPH?

ECLIPSE 4 ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1995-05-17. The listed applicant is Burdick, Inc.. The 510(k) number is K943959.

When did ECLIPSE 4 ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

ECLIPSE 4 ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1995-05-17, under 510(k) number K943959.

Who is the listed applicant for ECLIPSE 4 ELECTROCARDIOGRAPH?

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

What is the FDA product code for ECLIPSE 4 ELECTROCARDIOGRAPH?

The FDA product code for ECLIPSE 4 ELECTROCARDIOGRAPH is LOS.

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 Burdick, 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.

K952417QUEST EXERCISE STRESS SYSTEMK954267BURDICK 200 PULSE OXIMETERK946281ECLIPSE 4 ELECTROCARDIOGRAPHK945985PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400K942438ALTAIR 6100 CASSETTE RECORDER

Related Devices (Code: LOS)

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.

K090895EKG-PLUS II SOFTWAREBionet Co., Ltd.K083749CARDIOVIEW32 REVIEW MODULEQrs Diagnostic, LLCK073376PHILIPS ECG ALGORITHMPhilips Medical SystemsK023034CARDIOTOUCH-3000Bionet Company, Ltd.K011328CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPHBionet Company, Ltd.K993616CARDIO-CARD INTERPRETATION SYSTEM INasiff Assoc., 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.

↑