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FDA 510(k)

Avologi Gel Primer (Model: Av25)

K-Number: K220735 · 2023-09-15

ApplicantPremier North America, Inc.
Decision Date2023-09-15
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Avologi Gel Primer (Model: Av25) is the device name listed in this FDA 510(k) record. The listed applicant is Premier North America, Inc.. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K220735. 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 Avologi Gel Primer (Model: Av25)?

Avologi Gel Primer (Model: Av25) is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is Premier North America, Inc.. The 510(k) number is K220735.

When did Avologi Gel Primer (Model: Av25) receive FDA 510(k) clearance?

Avologi Gel Primer (Model: Av25) received FDA 510(k) clearance on 2023-09-15, under 510(k) number K220735.

Who is the listed applicant for Avologi Gel Primer (Model: Av25)?

The FDA 510(k) record lists Premier North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avologi Gel Primer (Model: Av25)?

The FDA product code for Avologi Gel Primer (Model: Av25) is GYB.

Other records listing Premier North America, Inc. 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.

K233862NUNA LUX (NUNL528)K232656BLU TOTALE (Model: ENEOB852)K214100LuminiceK213841ENEO TOTALE (Model: ENEOT947)K181659Avologi ENEO

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.K222770Conductive GelTop-Rank Health Care Co., Ltd.K221724Conductive GelTone-A-Matic International, Inc.K212325EEG-acpSomnomedics GmbHK212326AC Cream - Conductive pasteSpes Medica SrlK212787GT5 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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