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FDA 510(k)

MODEL 1309 AUDIO MONITOR

K-Number: K790664 · 1979-04-23

ApplicantLife-Tech Instruments, Inc.
Decision Date1979-04-23
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODEL 1309 AUDIO MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Instruments, Inc.. It received FDA 510(k) clearance on 1979-04-23 under 510(k) number K790664. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 1309 AUDIO MONITOR?

MODEL 1309 AUDIO MONITOR is a medical device that received FDA 510(k) clearance on 1979-04-23. The listed applicant is Life-Tech Instruments, Inc.. The 510(k) number is K790664.

When did MODEL 1309 AUDIO MONITOR receive FDA 510(k) clearance?

MODEL 1309 AUDIO MONITOR received FDA 510(k) clearance on 1979-04-23, under 510(k) number K790664.

Who is the listed applicant for MODEL 1309 AUDIO MONITOR?

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

What is the FDA product code for MODEL 1309 AUDIO MONITOR?

The FDA product code for MODEL 1309 AUDIO MONITOR is IKN.

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Other records listing Life-Tech 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.

K812177LIFE-TECH #1857 PRESSURE/POLOT MODULEK812179LIFE-TECH #1753 BIOFEEDBACK TRAINERK812180LIFE-TECH #5102 VISULABK812178LIFE-TECH #'S 1106/1156 UROLABSK800112AMBLYOPIA TRAINERK790663MODEL 1750 STANDING URINAL

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Related Devices (Code: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, Inc.

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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