Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AMPLAID MK22

K-Number: K972959 · 1998-02-06

ApplicantAmplifon S.P.A.
Decision Date1998-02-06
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AMPLAID MK22 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 1998-02-06 under 510(k) number K972959. 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 MK22?

AMPLAID MK22 is a medical device that received FDA 510(k) clearance on 1998-02-06. The listed applicant is Amplifon S.P.A.. The 510(k) number is K972959.

When did AMPLAID MK22 receive FDA 510(k) clearance?

AMPLAID MK22 received FDA 510(k) clearance on 1998-02-06, under 510(k) number K972959.

Who is the listed applicant for AMPLAID MK22?

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 MK22?

The FDA product code for AMPLAID MK22 is GWF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SERIESK971740AMPLAID MK12K974235AMPLAID AM50K972862AMPLAID 171S

View all 8 devices →

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.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx Neuroscience

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.

↑