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FDA 510(k)

EVOKED POTENTIAL CAP W/EVOKED POTENTIAL

K-Number: K830598 · 1983-03-24

ApplicantPrecision Cap Systems
Decision Date1983-03-24
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EVOKED POTENTIAL CAP W/EVOKED POTENTIAL is the device name listed in this FDA 510(k) record. The listed applicant is Precision Cap Systems. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830598. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVOKED POTENTIAL CAP W/EVOKED POTENTIAL?

EVOKED POTENTIAL CAP W/EVOKED POTENTIAL is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Precision Cap Systems. The 510(k) number is K830598.

When did EVOKED POTENTIAL CAP W/EVOKED POTENTIAL receive FDA 510(k) clearance?

EVOKED POTENTIAL CAP W/EVOKED POTENTIAL received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830598.

Who is the listed applicant for EVOKED POTENTIAL CAP W/EVOKED POTENTIAL?

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

What is the FDA product code for EVOKED POTENTIAL CAP W/EVOKED POTENTIAL?

The FDA product code for EVOKED POTENTIAL CAP W/EVOKED POTENTIAL is GXY.

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Other records listing Precision Cap Systems 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.

K830602PRECISION CAP STRAPSK830597BABY CAP, ELECTRODE SET & BOARD ADAPTORK830599LOCALIZING ELECTRODEK830601FOAMIES DIAPOS. FOAM RUBBER PADSK830521PRECISION EEG CAP W/ELECTRODE SET ANDK830600REFERENCE & MONITORING ELECTRODE

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Related Devices (Code: GXY)

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.

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,LtdK260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed Europe

Official Source

View on FDA Database →

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