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FDA 510(k)

MODEL E 600 ELECTROCARDIOGRAPH

K-Number: K860767 · 1986-04-23

ApplicantKone Instruments, Inc.
Decision Date1986-04-23
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL E 600 ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Kone Instruments, Inc.. It received FDA 510(k) clearance on 1986-04-23 under 510(k) number K860767. 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 MODEL E 600 ELECTROCARDIOGRAPH?

MODEL E 600 ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1986-04-23. The listed applicant is Kone Instruments, Inc.. The 510(k) number is K860767.

When did MODEL E 600 ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

MODEL E 600 ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1986-04-23, under 510(k) number K860767.

Who is the listed applicant for MODEL E 600 ELECTROCARDIOGRAPH?

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

What is the FDA product code for MODEL E 600 ELECTROCARDIOGRAPH?

The FDA product code for MODEL E 600 ELECTROCARDIOGRAPH is DSI.

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Other records listing Kone Instruments, Inc. as applicant

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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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