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The DRG Conventional Electronic Digital Stethoscope can be used as a standard stethoscope or as an electronic digital stethoscope. The additional stethoscope features allow the user to digitally record, amplify or replay sounds associated with the heart, artery, veins and other internal organs. The sounds can be replayed at different speeds.

Conventional Electronic Digital Stethoscope

This document is a marketing clearance letter from the FDA for a conventional electronic digital stethoscope (K991714) and does not contain the specific details about acceptance criteria or a study that proves the device meets such criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

Therefore, the device was cleared based on substantial equivalence to a predicate device, not on meeting specific acceptance criteria proven by a new performance study. Information about acceptance criteria and a detailed study fulfilling those criteria would typically be found in the 510(k) submission itself, which is not provided here.

Based on the provided text, I cannot answer the questions about acceptance criteria or a specific study proving the device meets them because the document is an FDA clearance letter, not the submission containing that information.

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