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SDYClass II

Loss Of Pulse Notification Software

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

SDY is the FDA product code for Loss Of Pulse Notification Software, 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 loss of pulse. This device is not intended to provide a diagnosis". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SDY
Device name
Loss Of Pulse Notification Software
FDA definition
A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying loss of pulse. 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
1
Ingested recalls
0

Clearances, product code SDY

By decision year
1 clearance under product code SDY with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SDY by decision year
YearClearances
20251

Applicants with the most clearances

Product code SDY
Applicants holding the most 510(k) clearances under product code SDY
ApplicantClearances
Fitbit LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code