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The Flo-Rite Conserving Device Regulator is intended for prescription use only, to be used in conjunction with a portable oxygen tank for supplemental oxygen therapy for in home or ambulatory application.

Flo-Rite, Flo-Rite II, Nuematix, Simpulse and Simpulse II.

This document is a 510(k) premarket notification decision letter from the FDA to Ameriflo Corporation regarding their respiratory assist devices (Flo-Rite, Flo-Rite II, Neumatix, Simpulse, and Simpulse II). It states that the devices are substantially equivalent to legally marketed predicate devices, allowing them to be marketed.

Therefore, this document does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. It is a regulatory approval document, not a clinical study report.

The information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, ground truth, etc.) would typically be found in a clinical study report or a different section of a 510(k) submission that details performance testing. This letter simply indicates that the FDA has reviewed the submission and found the device to be substantially equivalent.

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