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FDA 510(k)

WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L)

K-Number: K901619 · 1991-09-05

ApplicantWex Medical Instrumentation Co.
Decision Date1991-09-05
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L) is the device name listed in this FDA 510(k) record. The listed applicant is Wex Medical Instrumentation Co.. It received FDA 510(k) clearance on 1991-09-05 under 510(k) number K901619. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L)?

WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L) is a medical device that received FDA 510(k) clearance on 1991-09-05. The listed applicant is Wex Medical Instrumentation Co.. The 510(k) number is K901619.

When did WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L) receive FDA 510(k) clearance?

WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L) received FDA 510(k) clearance on 1991-09-05, under 510(k) number K901619.

Who is the listed applicant for WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L)?

The FDA 510(k) record lists Wex Medical Instrumentation Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L)?

The FDA product code for WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L) is LOS.

Related Clinical Trials

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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.

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