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FDA 510(k)

MK6 ERA SYSTEM

K-Number: K810473 · 1981-04-29

ApplicantAmplaid USA, Inc.
Decision Date1981-04-29
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MK6 ERA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Amplaid USA, Inc.. It received FDA 510(k) clearance on 1981-04-29 under 510(k) number K810473. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MK6 ERA SYSTEM?

MK6 ERA SYSTEM is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Amplaid USA, Inc.. The 510(k) number is K810473.

When did MK6 ERA SYSTEM receive FDA 510(k) clearance?

MK6 ERA SYSTEM received FDA 510(k) clearance on 1981-04-29, under 510(k) number K810473.

Who is the listed applicant for MK6 ERA SYSTEM?

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

What is the FDA product code for MK6 ERA SYSTEM?

The FDA product code for MK6 ERA SYSTEM is GWJ.

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Other records listing Amplaid USA, 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.

K861014AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)K832510EVOKED POTENTIALS SYSTEM MK10K810482SOMATOSENSORY STIMULATORK810481VISUAL PATTERN REVERSAL GEN. & PHOTIC S.K802963101, 151, 161 PORTABLE AUDIOMETERSK802097SELF-RECORDING ADMITTANCE METER 709

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Related Devices (Code: GWJ)

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.

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing Systems

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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