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Summary - Accessdata FDA - Food and Drug Administration - accessdata fda

Summary - Accessdata FDA - Food and Drug Administration - accessdata fda 2025

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The document is a 510(k) summary for the Apps-HealthOl, a data management software developed by Andon Health Co., Ltd. It outlines the device's intended use as an aid for individuals to review and analyze health data from blood pressure monitors and scales in home settings. The summary includes details about the device's classification, performance testing, and its substantial equivalence to a predicate device, confirming that it meets safety and effectiveness standards as per FDA regulations.

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What is the difference between FDA and FDA 510k?

The main distinction between the FDA vs FDA 510(k) is that the FDA oversees total product safety, whereas FDA 510(k) is a premarket submission procedure for medical device clearance based on equivalence.

What does the FDA do summary?

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation.

What is the FDA 510k summary?

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FDC Act) that is not subject to premarket approval.

What is the FDA 510k clearance?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

What is the 510k FDA summary?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the devices intended

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