Medical Device Manufacturer · CN , Shenzhen

Shenzhen Comen Medical Instruments Co.,Ltd - FDA 510(k) Cleared Devic...

5 submissions · 5 cleared · Since 2018

Recent clearances: Multi-parameter Patient Monitor (N10), Sequential Compression System (SCD600), Multi-Parameter Patient Monitor

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Shenzhen Comen Medical Instruments Co.,Ltd Cardiovascular ✕

5 devices

1-5 of 5

Cleared Dec 17, 2025

Multi-parameter Patient Monitor (N10)

Cardiovascular · 271d

Cleared Dec 08, 2025

Sequential Compression System (SCD600)

Cardiovascular · 319d

Cleared Dec 29, 2022

Multi-Parameter Patient Monitor

Cardiovascular · 582d

Cleared Dec 13, 2019

C50 and C80 Multi-parameter Patient Monitor

Cardiovascular · 232d

Cleared Aug 16, 2018

Multi-parameter Patient Monitor, models C30

Cardiovascular · 283d