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FDA 510(k)

MODEL ELI 200 ELECTROCARDIOGRAPH

K-Number: K920626 · 1992-09-04

ApplicantMortara Instrument, Inc.
Decision Date1992-09-04
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

MODEL ELI 200 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 1992-09-04 under 510(k) number K920626. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL ELI 200 ELECTROCARDIOGRAPH?

MODEL ELI 200 ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1992-09-04. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K920626.

When did MODEL ELI 200 ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

MODEL ELI 200 ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1992-09-04, under 510(k) number K920626.

Who is the listed applicant for MODEL ELI 200 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 200 ELECTROCARDIOGRAPH?

The FDA product code for MODEL ELI 200 ELECTROCARDIOGRAPH is LOS.

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Other records listing Mortara Instrument, 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.

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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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