510(k) K260490

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) by Shenzhen Ninenovo Technology Limited — Product Code DQA

K260490 is an FDA 510(k) premarket notification submitted by Shenzhen Ninenovo Technology Limited for the device "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)". The FDA issued a decision of Substantially Equivalent on Oct 2, 2026. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 2, 2026
Date Received
Feb 13, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type
510(k)

Source: FDA 510(k) database entry for K260490. Report a data issue: hello@regdatalab.com.