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510(k) clearances

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)

Shenzhen Ninenovo Technology Limited · Cardiovascular

K260490Substantially EquivalentTraditionalDQA
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
Cardiovascular
Address 1
B801,Sz-Nelb, # 20 Gaoxin S.7th Rd.,Gaoxin District Communit
Address 2
Yuehai Subdistrict, Nanshan District
Statement or summary
Summary
Product code
DQA
Zip code
518055
Applicant
Shenzhen Ninenovo Technology Limited
Decision date
2026-10-02
Decision code
SESE
Country code
CN
Device name
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)
Advisory committee
CV
Contact
Guoxing Wang
K number
K260490
Date received
2026-02-13
Review advisory committee
AN
Postal code
518055
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Oximeter
Medical specialty description
Cardiovascular
Regulation number
870.2700
Device class
2
Registration number
3020924771, 3037007069, 3026960443, 3018783553, 3034603279, 3014506106, 3030446844, 3013826848, 3038761440, 3003622639, 8030978, 3032391, 3007413079, 3011782009, 3021632375, 3007307487, 3008570547, 3009831876, 2221819, 3003965134, 3042156936, 3003832357, 3011353843, 3013545943, 1651104, 3020460367, 9614500, 3014389131, 3010526986, 3008505660, 3008164770, 3004415095, 3020018, 3008729547, 2183613, 3011353016, 3027510187, 3013689228, 1320894, 3000206696 +360 more
FEI number
3020924771, 3037007069, 3026960443, 3000718682, 3018783553, 3034603279, 3014506106, 3030446844, 3000210620, 3013826848, 3038761440, 3003622639, 1000117260, 3007413079, 3021632375, 3007307487, 3008570547, 3009831876, 2221819, 3003965134, 3042156936, 3003832357, 3002807850, 3011353843, 3013545943, 3020460367, 2250033, 1000114111, 3014389131, 3010526986, 3008505660, 3008164770, 3004415095, 3020018, 3008729547, 3002681132, 2183613, 3011353016, 3027510187, 3013689228 +360 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.