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FDA 510(k)

AMPLAID MK12

K-Number: K971740 · 1998-03-16

ApplicantAmplifon S.P.A.
Decision Date1998-03-16
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AMPLAID MK12 is the device name listed in this FDA 510(k) record. The listed applicant is Amplifon S.P.A.. It received FDA 510(k) clearance on 1998-03-16 under 510(k) number K971740. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMPLAID MK12?

AMPLAID MK12 is a medical device that received FDA 510(k) clearance on 1998-03-16. The listed applicant is Amplifon S.P.A.. The 510(k) number is K971740.

When did AMPLAID MK12 receive FDA 510(k) clearance?

AMPLAID MK12 received FDA 510(k) clearance on 1998-03-16, under 510(k) number K971740.

Who is the listed applicant for AMPLAID MK12?

The FDA 510(k) record lists Amplifon S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMPLAID MK12?

The FDA product code for AMPLAID MK12 is GWF.

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Other records listing Amplifon S.P.A. 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.

K992370AMPLAID A724 AND A728K983915AMPLAID A315 AND A319K983712AMPLAID A311 SERIESK974235AMPLAID AM50K972959AMPLAID MK22K972862AMPLAID 171S

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Related Devices (Code: GWF)

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.

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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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