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FDA 510(k)

THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER

K-Number: K913356 · 1991-12-05

ApplicantMonitor Instruments, Inc.
Decision Date1991-12-05
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER 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 1991-12-05 under 510(k) number K913356. 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/DEMLAR MODEL MI-5000 AUDIOMETER?

THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER is a medical device that received FDA 510(k) clearance on 1991-12-05. The listed applicant is Monitor Instruments, Inc.. The 510(k) number is K913356.

When did THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER receive FDA 510(k) clearance?

THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER received FDA 510(k) clearance on 1991-12-05, under 510(k) number K913356.

Who is the listed applicant for THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER?

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/DEMLAR MODEL MI-5000 AUDIOMETER?

The FDA product code for THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER 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.

K922383THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO

Related Devices (Code: EWO)

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Official Source

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