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Summary - accessdata fda - accessdata fda 2025

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The document is a 510(k) summary for the Ultra DCI Model 5000, a diagnostic ultrasound system intended for cardiac imaging. It outlines the device's compliance with safety standards, its intended use by qualified physicians, and its substantial equivalence to previously cleared devices. The summary includes details about the device's features, including B-mode echocardiographic capabilities and ECG integration, as well as regulatory information from the FDA.

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Where can I see FDA approvals?

Most FDA-approved human drugs and therapeutic biological products are listed in Drugs @ FDA, a searchable database.

What is the FDA 510k summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, new devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

Where can I find the FDA summary basis of approval?

SBAs are available through the FDAs Freedom of Information Office, 301-443-6310, and from the National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161.

What is a summary basis of approval?

A document, ing to the FDA, that contains a summary of the safety and effectiveness data and information evaluated by FDA during the drug approval process. (21CFR314.

What is the FDA brief summary requirement?

The law requires that print ads making claims about a drug (product claim ads) include a brief summary with all the risks listed in the drugs prescribing information and at least one FDA-approved use of the drug. The brief summary generally includes: Who should not take the drug. When the drug should not be taken.

What is the summary of the FDA?

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.

Where can I find FDA 483 reports?

Form FDA 483 and establishment inspection reports for domestic and foreign companies may be found on the Office of Inspections and Investigations (OII) FOIA Electronic Reading Room. Visit the Inspections Dashboard for additional information.

Where can you find the information you need to submit a report to the FDA?

If you need information or if you have questions or comments about a medical product, please call the FDAs toll-free information line, 1-888-INFO-FDA (1-888-463-6332) Press 2 to report into MedWatch or for instructions.

Summary - accessdata fda - accessdata fda 2025

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