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FDA 510(k)

BABY CAP, ELECTRODE SET & BOARD ADAPTOR

K-Number: K830597 · 1983-03-24

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

Device Summary

BABY CAP, ELECTRODE SET & BOARD ADAPTOR 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 K830597. 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 BABY CAP, ELECTRODE SET & BOARD ADAPTOR?

BABY CAP, ELECTRODE SET & BOARD ADAPTOR 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 K830597.

When did BABY CAP, ELECTRODE SET & BOARD ADAPTOR receive FDA 510(k) clearance?

BABY CAP, ELECTRODE SET & BOARD ADAPTOR received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830597.

Who is the listed applicant for BABY CAP, ELECTRODE SET & BOARD ADAPTOR?

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 BABY CAP, ELECTRODE SET & BOARD ADAPTOR?

The FDA product code for BABY CAP, ELECTRODE SET & BOARD ADAPTOR 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 STRAPSK830598EVOKED POTENTIAL CAP W/EVOKED POTENTIALK830599LOCALIZING 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 →

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

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