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FDA 510(k)

ELITE II ELECTROCARDIOGRAPH,MODIFIED

K-Number: K915327 · 1992-10-09

ApplicantSiemens Burdick, Inc.
Decision Date1992-10-09
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

ELITE II ELECTROCARDIOGRAPH,MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Burdick, Inc.. It received FDA 510(k) clearance on 1992-10-09 under 510(k) number K915327. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELITE II ELECTROCARDIOGRAPH,MODIFIED?

ELITE II ELECTROCARDIOGRAPH,MODIFIED is a medical device that received FDA 510(k) clearance on 1992-10-09. The listed applicant is Siemens Burdick, Inc.. The 510(k) number is K915327.

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

ELITE II ELECTROCARDIOGRAPH,MODIFIED received FDA 510(k) clearance on 1992-10-09, under 510(k) number K915327.

Who is the listed applicant for ELITE II ELECTROCARDIOGRAPH,MODIFIED?

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

What is the FDA product code for ELITE II ELECTROCARDIOGRAPH,MODIFIED?

The FDA product code for ELITE II ELECTROCARDIOGRAPH,MODIFIED is LOS.

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Other records listing Siemens 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.

K915225MEGACARTK915202INTERNAL MODEM FOR THE E560 ELECTROCARDIOGRAPHK914969E350I ELECTROCARDIOGRAPHK913518TA620 TREADMILL CONTROLLERK910634DC200 DEFIBRILLATORK910867T600 TREADMILL

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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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