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FDA 510(k)

AC Cream - Conductive paste

K-Number: K212326 · 2021-12-01

ApplicantSpes Medica Srl
Decision Date2021-12-01
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AC Cream - Conductive paste is the device name listed in this FDA 510(k) record. The listed applicant is Spes Medica Srl. It received FDA 510(k) clearance on 2021-12-01 under 510(k) number K212326. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AC Cream - Conductive paste?

AC Cream - Conductive paste is a medical device that received FDA 510(k) clearance on 2021-12-01. The listed applicant is Spes Medica Srl. The 510(k) number is K212326.

When did AC Cream - Conductive paste receive FDA 510(k) clearance?

AC Cream - Conductive paste received FDA 510(k) clearance on 2021-12-01, under 510(k) number K212326.

Who is the listed applicant for AC Cream - Conductive paste?

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

What is the FDA product code for AC Cream - Conductive paste?

The FDA product code for AC Cream - Conductive paste is GYB.

Other records listing Spes Medica Srl 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.

K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping GridK192606SAC2 - Electrode CreamK192603Spes Medica Subdermal Needle ElectrodesK190050Tech Dots - Adhesive and conductive gel

Related Devices (Code: GYB)

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.

K243749Jmoon Conductive GelShenzhen Ulike Smart Electronics Co., Ltd.K220735Avologi Gel Primer (Model: Av25)Premier North America, Inc.K222770Conductive GelTop-Rank Health Care Co., Ltd.K221724Conductive GelTone-A-Matic International, Inc.K212325EEG-acpSomnomedics GmbHK212787GT5 conductive & abrasive gelWuhan Greentek Pty , 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.

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