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FDA 510(k)

M700 STRESS MONITOR

K-Number: K863466 · 1986-12-22

ApplicantKone Instruments, Inc.
Decision Date1986-12-22
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M700 STRESS MONITOR 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 1986-12-22 under 510(k) number K863466. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M700 STRESS MONITOR?

M700 STRESS MONITOR is a medical device that received FDA 510(k) clearance on 1986-12-22. The listed applicant is Kone Instruments, Inc.. The 510(k) number is K863466.

When did M700 STRESS MONITOR receive FDA 510(k) clearance?

M700 STRESS MONITOR received FDA 510(k) clearance on 1986-12-22, under 510(k) number K863466.

Who is the listed applicant for M700 STRESS MONITOR?

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 M700 STRESS MONITOR?

The FDA product code for M700 STRESS MONITOR is DRT.

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Other records listing Kone Instruments, 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: DRT)

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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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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