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FDA 510(k)

AMPLAID EMG15

K-Number: K884071 · 1989-02-27

ApplicantAmplus Corp.
Decision Date1989-02-27
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AMPLAID EMG15 is the device name listed in this FDA 510(k) record. The listed applicant is Amplus Corp.. It received FDA 510(k) clearance on 1989-02-27 under 510(k) number K884071. 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 EMG15?

AMPLAID EMG15 is a medical device that received FDA 510(k) clearance on 1989-02-27. The listed applicant is Amplus Corp.. The 510(k) number is K884071.

When did AMPLAID EMG15 receive FDA 510(k) clearance?

AMPLAID EMG15 received FDA 510(k) clearance on 1989-02-27, under 510(k) number K884071.

Who is the listed applicant for AMPLAID EMG15?

The FDA 510(k) record lists Amplus Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMPLAID EMG15?

The FDA product code for AMPLAID EMG15 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 Amplus Corp. 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.

K903066AMPLAID 770 ADMITTANCE METERK891988AMPLAID A308 CLINICAL AUDIOMETERK880059AMPLAID 309 CLINICAL AUDIOMETER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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