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Summary.pdf

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🔗 Source: accessdata.fda.gov
📊 Size: 478 KB
📄 Pages: 9 pages
⬇️ Downloads: 63

Summary

The FDA has determined that the Cosmed Q-NRG & Q-NRG+ Portable Metabolic Monitors are substantially equivalent to legally marketed predicate devices, and thus may be marketed, subject to general controls provisions of the Federal Food, Drug, and Cosmetic Act. The devices are indicated for measuring Resting Energy Expenditure in spontaneously breathing and ventilated patients, and are intended for use in professional healthcare facilities.

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The FDA has determined that the Cosmed Q-NRG & Q-NRG+ Portable Metabolic Monitors are substantially equivalent to legally marketed predicate devices, and thus...

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  • File Format: PDF
  • File Size: 478 KB
  • Pages: 9
  • Language: EN
  • Total Downloads: 63
  • Last Updated: 1 week ago

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