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FDA 510(k)

THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO

K-Number: K922383 · 1993-01-15

ApplicantMonitor Instruments, Inc.
Decision Date1993-01-15
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO is the device name listed in this FDA 510(k) record. The listed applicant is Monitor Instruments, Inc.. It received FDA 510(k) clearance on 1993-01-15 under 510(k) number K922383. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO?

THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO is a medical device that received FDA 510(k) clearance on 1993-01-15. The listed applicant is Monitor Instruments, Inc.. The 510(k) number is K922383.

When did THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO receive FDA 510(k) clearance?

THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO received FDA 510(k) clearance on 1993-01-15, under 510(k) number K922383.

Who is the listed applicant for THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO?

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

What is the FDA product code for THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO?

The FDA product code for THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO is EWO.

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Other records listing Monitor 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.

K913356THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER

Related Devices (Code: EWO)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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