510(k) clearance

Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14)

FDA 510(k) source

510(k) number

K260490

Applicant

Shenzhen Ninenovo Technology Limited

Decision date

Oct 2, 2026

Date received

Feb 13, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

DQA

Device type

Oximeter

Device class

Class II

Regulation

21 CFR 870.2700

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Shenzhen, CN