Medical Device Manufacturer · CN , Yuyao City

Ningbo Ouhan Medical Device Co., Ltd. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2021

Recent clearances: Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ningbo Ouhan Medical Device Co., Ltd. General Hospital ✕

1 devices

1-1 of 1

Cleared Sep 17, 2021

Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))

General Hospital · 302d

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 24, 2026