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FDA 510(k)

SNORING MICROPHONE, SM1

K-Number: K940015 · 1995-01-11

ApplicantPro-Tech, Inc.
Decision Date1995-01-11
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SNORING MICROPHONE, SM1 is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Tech, Inc.. It received FDA 510(k) clearance on 1995-01-11 under 510(k) number K940015. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SNORING MICROPHONE, SM1?

SNORING MICROPHONE, SM1 is a medical device that received FDA 510(k) clearance on 1995-01-11. The listed applicant is Pro-Tech, Inc.. The 510(k) number is K940015.

When did SNORING MICROPHONE, SM1 receive FDA 510(k) clearance?

SNORING MICROPHONE, SM1 received FDA 510(k) clearance on 1995-01-11, under 510(k) number K940015.

Who is the listed applicant for SNORING MICROPHONE, SM1?

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

What is the FDA product code for SNORING MICROPHONE, SM1?

The FDA product code for SNORING MICROPHONE, SM1 is MNR.

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Other records listing Pro-Tech, 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.

K940013BODY POSITION INDICATOR, MODEL BPI1K940014PLM SENSOR, MODEL PLM1K924752FREEDOM OXIMETER/EEG DIGITAL INTERFACEK923402CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSORK913396CANNULA STYLE THERMOCOUPLESK913395EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS

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Related Devices (Code: MNR)

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K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbHK254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLCK253148RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressK252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical

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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