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Kc 9)53 - accessdata fda

Kc 9)53 - accessdata fda 2025

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The document is a 510(k) premarket submission for the Echo Blaster 64 and Echo Blaster 128 ultrasound imaging systems manufactured by TELEMED. It provides identifying information, classification details, performance standards, indications for use, device descriptions, safety and effectiveness assessments, and compliance with medical device regulations. The systems are designed for various diagnostic applications including fetal, abdominal, pediatric, and cardiac imaging. The submission concludes that the devices are safe, effective, and substantially equivalent to previously cleared predicate devices.

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Click ‘Get Form’ to open the Kc 9)53 - accessdata fda document in the editor.
Begin by filling in the 'Identifying Information' section. Enter the manufacturer's name, address, telephone, fax, and email as specified.
Proceed to the 'Class and Predicate Information' section. Here, you will need to provide details about the classification name and predicate devices related to your submission.
In the 'Performance Standards' section, ensure that you list any applicable standards that your device meets, such as IEC or ISO standards.
Complete the 'Indication for Use' section by specifying all intended uses of the Echo Blaster systems. Be thorough in detailing each application.
Finally, review all sections for accuracy before saving or exporting your completed form. Utilize our platform's features to sign and share your document securely.

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The publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the FDC Act).

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The NDC, or National Drug Code, is a unique 10-digit or 11-digit, 3-segment number, and a universal product identifier for human drugs in the United States. The code is present on all prescription, over-the-counter and products and labels in the U.S. The NDC serves as the FDAs identifier for drugs.

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Look up the drug or biological product in Drugs @ FDA. Most FDA-approved human drugs and therapeutic biological products are listed in Drugs @ FDA, a searchable database. The database allows you to search by drug name, active ingredient, or application (NDA, ANDA, or BLA) number.

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Kc 9)53 - accessdata fda 2025

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