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FDA 510(k)

FOAMIES DIAPOS. FOAM RUBBER PADS

K-Number: K830601 · 1983-03-24

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

Device Summary

FOAMIES DIAPOS. FOAM RUBBER PADS 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 K830601. 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 FOAMIES DIAPOS. FOAM RUBBER PADS?

FOAMIES DIAPOS. FOAM RUBBER PADS 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 K830601.

When did FOAMIES DIAPOS. FOAM RUBBER PADS receive FDA 510(k) clearance?

FOAMIES DIAPOS. FOAM RUBBER PADS received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830601.

Who is the listed applicant for FOAMIES DIAPOS. FOAM RUBBER PADS?

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 FOAMIES DIAPOS. FOAM RUBBER PADS?

The FDA product code for FOAMIES DIAPOS. FOAM RUBBER PADS 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 POTENTIALK830597BABY CAP, ELECTRODE SET & BOARD ADAPTORK830599LOCALIZING ELECTRODEK830521PRECISION EEG CAP W/ELECTRODE SET ANDK830600REFERENCE & MONITORING ELECTRODE

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Related Devices (Code: GXY)

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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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