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FDA 510(k)

SAC2 - Electrode Cream

K-Number: K192606 · 2020-01-17

ApplicantSpes Medica Srl
Decision Date2020-01-17
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SAC2 - Electrode Cream 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 2020-01-17 under 510(k) number K192606. 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 SAC2 - Electrode Cream?

SAC2 - Electrode Cream is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Spes Medica Srl. The 510(k) number is K192606.

When did SAC2 - Electrode Cream receive FDA 510(k) clearance?

SAC2 - Electrode Cream received FDA 510(k) clearance on 2020-01-17, under 510(k) number K192606.

Who is the listed applicant for SAC2 - Electrode Cream?

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 SAC2 - Electrode Cream?

The FDA product code for SAC2 - Electrode Cream 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 GridK212326AC Cream - Conductive pasteK192603Spes 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 GmbHK212326AC Cream - Conductive pasteSpes Medica Srl

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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