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FDA 510(k)

ELITE II ELECTROCARDIOGRAPH

K-Number: K904032 · 1991-07-24

ApplicantBurdick Corp.
Decision Date1991-07-24
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

ELITE II ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Burdick Corp.. It received FDA 510(k) clearance on 1991-07-24 under 510(k) number K904032. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELITE II ELECTROCARDIOGRAPH?

ELITE II ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1991-07-24. The listed applicant is Burdick Corp.. The 510(k) number is K904032.

When did ELITE II ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

ELITE II ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1991-07-24, under 510(k) number K904032.

Who is the listed applicant for ELITE II ELECTROCARDIOGRAPH?

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

What is the FDA product code for ELITE II ELECTROCARDIOGRAPH?

The FDA product code for ELITE II ELECTROCARDIOGRAPH is LOS.

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Other records listing Burdick Corp. 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.

K942565ALTAIR-DISC RECORDERK941351BURDICK PRO2 OXIMETERK903565E560 ELECTROCARDIOGRAPHK900729NEOSERV 824K885085ERGOMED 840/ERGOMED 840LK892835E350 ELECTROCARDIOGRAPH

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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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