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510(k) K241789

Device
Non-Sterile Ultrasound Transmission Gels
Applicant
Hony Medical Co., Ltd.
510(k) number
K241789
Product code
MUI
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-24
Date received
2024-06-21
Regulation
892.1570
Classification name
Media, Coupling, Ultrasound
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Zhu Huina
Address
#12,9 Rd.,Changlong Ind.Zone, Taishan CN 529222 529222

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K163026Ultra/Phonic Scanning GelPharmaceutical Innovations, Inc.2018-01-09
K163027Ultra/Phonic Free Conductivity GelPharmaceutical Innovations, Inc.2018-01-09
K163023Other-Sonic Transmission GelPharmaceutical Innovations, Inc.2018-01-08
K163024Ultra/Phonic Conductivity GelPharmaceutical Innovations, Inc.2018-01-08
K163050Advance Medical Designs, Inc. Sterile Ultrasound GelAdvance Medical Designs, Inc.2017-10-25
K151070Sonishield 100 Antimicrobial Ultrasound GelQuotient Medical2016-01-13
K130581KONIX STERILE GELTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa2014-06-18
K131905SOLID GEL PADBluemtech2013-07-18
K130041SHEATHES STERILE ULTRASOUND GELSheathing Technologies, Inc.2013-02-06