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 a medical device manufactured by Premier North America, Inc.. It received FDA 510(k) clearance on 2023-09-15 under approval 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. It is manufactured by Premier North America, Inc.. The 510(k) number is K220735.
When was Avologi Gel Primer (Model: Av25) approved by the FDA?
Avologi Gel Primer (Model: Av25) received FDA 510(k) clearance on 2023-09-15, under approval number K220735.
What company makes Avologi Gel Primer (Model: Av25)?
Avologi Gel Primer (Model: Av25) is manufactured by Premier North America, Inc..
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 Devices by Premier North America, Inc.
Related Devices (Code: GYB)
K161654NuFACE Gel PrimerCarol Cole Company
K161715EndyGelEndymed Medical, Ltd.
K190050Tech Dots - Adhesive and conductive gelSpes Medica Srl
K200402DR-HO'S Electro Therapy Conductive GelGuangzhou Xinbo Electronic Co., Ltd.
K191975Elefix V Paste for EEG & EMGNihon Kohden Corporation
K192606SAC2 - Electrode CreamSpes Medica Srl
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.