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SBHClass II

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

21 CFR 862.1355 / Clinical Chemistry
FDA source (opens on fda.gov)

SBH is the FDA product code for Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter, a class II device type, regulated under 21 CFR 862.1355. FDA's definition for this code reads: "An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose management is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels across the range spanning clinically significant...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SBH
Device name
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
FDA definition
An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose management is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels across the range spanning clinically significant hypoglycemia and hyperglycemia levels in persons who are not on insulin and who do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose management are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices.
Regulation
21 CFR 862.1355
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code SBH

By decision year
3 clearances under product code SBH with a decision year between 2024 and 2026, 2026 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code SBH by decision year
YearClearances
20241
20262

Applicants with the most clearances

Product code SBH
Applicants holding the most 510(k) clearances under product code SBH
ApplicantClearances
Dexcom, Inc.2
Abbott Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code