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FDA 510(k)

IMPEDANCE METER ON-1

K-Number: K823227 · 1982-11-22

ApplicantKells Medical, Inc.
Decision Date1982-11-22
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IMPEDANCE METER ON-1 is the device name listed in this FDA 510(k) record. The listed applicant is Kells Medical, Inc.. It received FDA 510(k) clearance on 1982-11-22 under 510(k) number K823227. The device is classified under product code ETY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPEDANCE METER ON-1?

IMPEDANCE METER ON-1 is a medical device that received FDA 510(k) clearance on 1982-11-22. The listed applicant is Kells Medical, Inc.. The 510(k) number is K823227.

When did IMPEDANCE METER ON-1 receive FDA 510(k) clearance?

IMPEDANCE METER ON-1 received FDA 510(k) clearance on 1982-11-22, under 510(k) number K823227.

Who is the listed applicant for IMPEDANCE METER ON-1?

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

What is the FDA product code for IMPEDANCE METER ON-1?

The FDA product code for IMPEDANCE METER ON-1 is ETY.

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Other records listing Kells Medical, Inc. as applicant

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K926333CPR PLUSK890093PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SETK890094EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETK890095PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETK861972DERMISTRIPK844463DERMIDRESS

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Related Devices (Code: ETY)

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K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.K162210touchTympMaico Diagnostics GmbHK161707Madsen ZodiacGn OtometricsK121847TITANInteracoustics A/SK083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEInteracoustics AS

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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