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

Photoplethysmograph Analysis Software For Over-The-Counter Use

21 CFR 870.2790 / Cardiovascular
FDA source (opens on fda.gov)

QDB is the FDA product code for Photoplethysmograph Analysis Software For Over-The-Counter Use, a class II device type, regulated under 21 CFR 870.2790. FDA's definition for this code reads: "A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QDB
Device name
Photoplethysmograph Analysis Software For Over-The-Counter Use
FDA definition
A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.
Regulation
21 CFR 870.2790
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
5
Ingested recalls
0

Clearances, product code QDB

By decision year
5 clearances under product code QDB with a decision year between 2018 and 2023, 2022 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QDB by decision year
YearClearances
20181
20211
20222
20231

Applicants with the most clearances

Product code QDB
Applicants holding the most 510(k) clearances under product code QDB
ApplicantClearances
Apple Inc.3
Apple, Inc.1
Fitbit LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code