K-number	K250837
Device name	Pulse Oximeter
Applicant	Shanghai Berry Electronic Tech Co., Ltd.
Product code	DQA
Device class	Class II
Decision date	Sep 25, 2025
Decision	Substantially Equivalent
Regulation	870.2700

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Pulse Oximeter is intended for spot-checking to measure and display functional arterial hemoglobin saturation (SpO2) and pulse rate. It is designed for use by adult, adolescent, and child users in hospitals, hospital facilities, and home healthcare environments.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Pulse Oximeter

Everything you need for a 510(k) submission. Nothing you don't.