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FDA 510(k)

MODEL ELI-100/ST ELECTROCARDIOGRAPH

K-Number: K895232 · 1989-12-13

ApplicantMortara Instrument, Inc.
Decision Date1989-12-13
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

MODEL ELI-100/ST ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Mortara Instrument, Inc.. It received FDA 510(k) clearance on 1989-12-13 under 510(k) number K895232. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL ELI-100/ST ELECTROCARDIOGRAPH?

MODEL ELI-100/ST ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1989-12-13. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K895232.

When did MODEL ELI-100/ST ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

MODEL ELI-100/ST ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1989-12-13, under 510(k) number K895232.

Who is the listed applicant for MODEL ELI-100/ST ELECTROCARDIOGRAPH?

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

What is the FDA product code for MODEL ELI-100/ST ELECTROCARDIOGRAPH?

The FDA product code for MODEL ELI-100/ST ELECTROCARDIOGRAPH is LOS.

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Other records listing Mortara Instrument, Inc. as applicant

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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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