510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QUOClass II

Adjunctive Heart Failure Status Indicator

21 CFR 870.2200 / Cardiovascular
FDA source (opens on fda.gov)

QUO is the FDA product code for Adjunctive Heart Failure Status Indicator, a class II device type, regulated under 21 CFR 870.2200. FDA's definition for this code reads: "The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QUO
Device name
Adjunctive Heart Failure Status Indicator
FDA definition
The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Regulation
21 CFR 870.2200
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code QUO

By decision year
4 clearances under product code QUO with a decision year between 2022 and 2025, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QUO by decision year
YearClearances
20221
20231
20241
20251

Applicants with the most clearances

Product code QUO
Applicants holding the most 510(k) clearances under product code QUO
ApplicantClearances
Ultromics, Ltd.2
Avicena, LLC1
Icardio.Ai1

Companies listing this code with FDA

Companies whose registered establishments list this code