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

Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

21 CFR 870.2785 / Cardiovascular
FDA source (opens on fda.gov)

QME is the FDA product code for Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate, a class II device type, regulated under 21 CFR 870.2785. FDA's definition for this code reads: "The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy". As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QME
Device name
Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
FDA definition
The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy.
Regulation
21 CFR 870.2785
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
13
Ingested recalls
0

Clearances, product code QME

By decision year
13 clearances under product code QME with a decision year between 2021 and 2026, 2026 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code QME by decision year
YearClearances
20212
20221
20231
20243
20252
20264

Applicants with the most clearances

Product code QME
Applicants holding the most 510(k) clearances under product code QME
ApplicantClearances
Oxehealth Ltd5
Mindset Medical, Inc.2
PanopticAI Technologies Limited2
Faceheart Corp.1
Nuralogix Corporation1
Presage Security, Inc. d/b/a Presage Technologies, Inc.1
Qompium NV1

Companies listing this code with FDA

Companies whose registered establishments list this code