510(k) clearances

Control-IQ+ technology

Tandem Diabetes Care, Inc. · Clinical Chemistry

K243823Substantially EquivalentTraditionalQJI
Open FDA's page for this record
Third party flag
N
City
San Diego
Advisory committee description
Clinical Chemistry
Address 1
12400 High Bluff Dr.
Statement or summary
Summary
Product code
QJI
Zip code
92130
Applicant
Tandem Diabetes Care, Inc.
Decision date
2025-02-24
Decision code
SESE
Country code
US
Device name
Control-IQ+ technology
Advisory committee
CH
Contact
Christin Dunn
K number
K243823
State
CA
Date received
2024-12-12
Review advisory committee
CH
Postal code
92130
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
3013756811, 3016798778, 3016540876, 3019004087, 3008824097, 3007981285, 3026266833, 3047799708, 3014585508, 2032227, 1220477, 1220973, 3015192982, 2246552
FEI number
3013756811, 3003166194, 3016798778, 3016540876, 3019004087, 3008824097, 3007981285, 3026266833, 3047799708, 3014585508, 1220477, 1220973, 3015192982, 2246552
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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.