510(k) clearances

Biofourmis Everion+ (G2)

Biofourmis Singapore Pte., Ltd. · Cardiovascular

K233418Substantially EquivalentTraditionalMSX
Open FDA's page for this record
Third party flag
N
City
Singapore
Advisory committee description
Cardiovascular
Address 1
2 Venture Dr., Vision Exchange, #23-01
Statement or summary
Summary
Product code
MSX
Zip code
608526
Applicant
Biofourmis Singapore Pte., Ltd.
Decision date
2024-05-09
Decision code
SESE
Country code
SG
Device name
Biofourmis Everion+ (G2)
Advisory committee
CV
Contact
Seth Kuzdzal
K number
K233418
Date received
2023-10-10
Review advisory committee
CV
Postal code
608526
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Network And Communication, Physiological Monitors
Medical specialty description
Cardiovascular
Regulation number
870.2300
Device class
2
Registration number
3003263092, 3010698831, 3003971136, 3013546957, 3006240053, 3008729547, 1000122786, 3016701404, 3015529350, 3009595635, 3038761440, 3010703925, 2080783, 3015437214, 3011166598, 3016595211, 1824206, 3009499478, 3007603826, 3013783488, 1831750, 3000126629, 9610105, 3016670256, 3009673645, 3016852448, 8020045, 3004906872, 3000976525, 3015134004, 3015173634, 9611500, 3007481893, 3044754336, 9680215, 1651104, 3008058135, 3009973336, 3013596024, 3013500228 +34 more
FEI number
3003263092, 3010698831, 3002806783, 3003971136, 3013546957, 3006240053, 3006254866, 6736, 3008729547, 1000122786, 3001084824, 3016701404, 3015529350, 3009595635, 3038761440, 3010703925, 2080783, 3015437214, 3011166598, 3016595211, 1824206, 3009499478, 3007603826, 3013783488, 1831750, 3000126629, 3016670256, 3002807720, 3009673645, 3016852448, 3004906872, 3000976525, 3002737156, 3015134004, 3015173634, 3001104093, 3044754336, 3008058135, 3002807167, 3009973336 +34 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.