510(k) clearances

iOS CamAPS FX

CamDiab · Clinical Chemistry

K261896Substantially EquivalentTraditionalQJI
Open FDA's page for this record
Third party flag
N
City
London
Advisory committee description
Clinical Chemistry
Address 1
20-22 Wenlock Rd.
Statement or summary
Summary
Product code
QJI
Zip code
N1 7GU
Applicant
CamDiab
Decision date
2026-09-16
Decision code
SESE
Country code
GB
Device name
iOS CamAPS FX
Advisory committee
CH
Contact
Roman Hovorka
K number
K261896
Date received
2026-06-08
Review advisory committee
CH
Postal code
N1 7GU
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Interoperable Automated Glycemic Controller
Medical specialty description
Clinical Chemistry
Regulation number
862.1356
Device class
2
Registration number
3019004087, 1220973, 3008824097, 1220477, 3016798778, 3016540876, 2246552, 3007981285, 3015192982, 2032227, 3026266833, 3013756811, 3047799708, 3014585508
FEI number
3019004087, 1220973, 3008824097, 1220477, 3016798778, 3016540876, 2246552, 3007981285, 3015192982, 3026266833, 3003166194, 3013756811, 3047799708, 3014585508
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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.