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Consulting - World Leading Consultancy:. FDA 510(k), UL, CCC Mark, CE Marking. Your One-Stop Reliable Partner in International Trade! FDA News - US Agent. February 11, 2002:. The FDA requires that all non-US medical device manufacturers wishing to market their products in the United States must have a local representative in the US, i.e. the "US Agent". December 12, 2003:. All foreign food facilities must include the name of a "US Agent". With their registration with FDA. FDA News - Payment. CE Marking i...
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Fully automatic blood pressure monitor uses oscilometric method for obtaining blood pressure reading by detecting changes in arterial blood flow. An automatic electronic blood pressure monitor for the arm with pulse rate and arrhythmia detection. Electronic Blood-Pressure Monitor (Automatic, Arm). An automatic electronic blood pressure monitor for the wrist with pulse rate and arrhythmia detection. Electronic Blood-Pressure Monitor (Automatic, wrist). Arm Blood Pressure Monitor. Damage to your device.
FDA 510k Database | Comprehensive Medical Device Directory
The directory of FDA-cleared medical devices. Comprehensive, convenient and easy to use. 1996 — present. Product Codes and Device Classses. Lin-Zhi International, Inc. Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5Ml), (15Ml); Controls; (5Ml), (15Ml). Enzyme Immunoassay, Opiates. Substantial Equivalence - CLIA Submission. Alere Scarborough, Inc D/B/A Binax, Inc. Alere I Influenza A and B, Alere I Instrument, Alere I Influenza A and B Control Swab Kit. Substantial Equivalence - CLIA Submission.
FDA 510(k) Applications Database
Welcome to 510kDecisions.com. This website contains over 132,000 FDA 510(k) applications and decisions collected since May, 1976 from the U.S. Food and Drug Administration's publicly available databases of FDA Device Approvals and Clearances. Additionally, we have provided convenient cross-linking of records by applicant company name, contact name, device classification, and product code. Things You Can Do With This Website:. Check the status of an FDA 510(k) Application by browsing to it by company name.
