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FDA 510(k)

E350I ELECTROCARDIOGRAPH

K-Number: K914969 · 1992-03-26

ApplicantSiemens Burdick, Inc.
Decision Date1992-03-26
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

E350I ELECTROCARDIOGRAPH 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 1992-03-26 under 510(k) number K914969. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E350I ELECTROCARDIOGRAPH?

E350I ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1992-03-26. The listed applicant is Siemens Burdick, Inc.. The 510(k) number is K914969.

When did E350I ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

E350I ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1992-03-26, under 510(k) number K914969.

Who is the listed applicant for E350I ELECTROCARDIOGRAPH?

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 E350I ELECTROCARDIOGRAPH?

The FDA product code for E350I ELECTROCARDIOGRAPH 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.

K915327ELITE II ELECTROCARDIOGRAPH,MODIFIEDK915225MEGACARTK915202INTERNAL MODEM FOR THE E560 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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