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 MK15 (EVOKED POTENTIAL SYSTEM)

K-Number: K861014 · 1986-08-20

ApplicantAmplaid USA, Inc.
Decision Date1986-08-20
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AMPLAID MK15 (EVOKED POTENTIAL 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 1986-08-20 under 510(k) number K861014. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)?

AMPLAID MK15 (EVOKED POTENTIAL SYSTEM) is a medical device that received FDA 510(k) clearance on 1986-08-20. The listed applicant is Amplaid USA, Inc.. The 510(k) number is K861014.

When did AMPLAID MK15 (EVOKED POTENTIAL SYSTEM) receive FDA 510(k) clearance?

AMPLAID MK15 (EVOKED POTENTIAL SYSTEM) received FDA 510(k) clearance on 1986-08-20, under 510(k) number K861014.

Who is the listed applicant for AMPLAID MK15 (EVOKED POTENTIAL 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 AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)?

The FDA product code for AMPLAID MK15 (EVOKED POTENTIAL SYSTEM) is GWL.

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 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.

K832510EVOKED POTENTIALS SYSTEM MK10K810473MK6 ERA SYSTEMK810482SOMATOSENSORY STIMULATORK810481VISUAL PATTERN REVERSAL GEN. & PHOTIC S.K802963101, 151, 161 PORTABLE AUDIOMETERSK802097SELF-RECORDING ADMITTANCE METER 709

View all 8 devices →

Related Devices (Code: GWL)

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.

K243746Delphi AmplifierQuantalx NeroscienceK242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.K240646DreamClearSomnomed Technologies Inc., Doing Business AS RemwareK232210X-trodes System MX-TrodesK230148VlabDormotech Medical, Ltd.

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.

↑