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FDA 510(k)

MAX-1 (EXERCISE ELECTROCARDIOGRAPH)

K-Number: K890323 · 1989-06-16

ApplicantMarquette Electronics, Inc.
Decision Date1989-06-16
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAX-1 (EXERCISE ELECTROCARDIOGRAPH) is the device name listed in this FDA 510(k) record. The listed applicant is Marquette Electronics, Inc.. It received FDA 510(k) clearance on 1989-06-16 under 510(k) number K890323. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAX-1 (EXERCISE ELECTROCARDIOGRAPH)?

MAX-1 (EXERCISE ELECTROCARDIOGRAPH) is a medical device that received FDA 510(k) clearance on 1989-06-16. The listed applicant is Marquette Electronics, Inc.. The 510(k) number is K890323.

When did MAX-1 (EXERCISE ELECTROCARDIOGRAPH) receive FDA 510(k) clearance?

MAX-1 (EXERCISE ELECTROCARDIOGRAPH) received FDA 510(k) clearance on 1989-06-16, under 510(k) number K890323.

Who is the listed applicant for MAX-1 (EXERCISE ELECTROCARDIOGRAPH)?

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

What is the FDA product code for MAX-1 (EXERCISE ELECTROCARDIOGRAPH)?

The FDA product code for MAX-1 (EXERCISE ELECTROCARDIOGRAPH) is DSI.

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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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