FDA.report

510(k) K241285

Device
Disposable Endoscope Valves Set (AF series)
Applicant
Alton (Shanghai) Medical Instruments Co., Ltd.
510(k) number
K241285
Product code
ODC
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-01
Date received
2024-05-07
Regulation
876.1500
Classification name
Endoscope Channel Accessory
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Johnny Song
Address
#24 Bldg. Jinshao Rd. 1688.Baoshan District. Shanghai CN 200949 200949

FDA Registration Numbers

Source Documents

510(k) summary PDF

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