Vyaire medical file identification: com-(b)(4).H10: a vyaire field service representative(fsr) evaluated the device onsite and performed ddi (dynamic displacement indicator) calibration,driver controller board cal,patient circuit calibration (passed) and ventilation performance check (passed).The unit passed all performance and safety checks.The oscillator is no longer fluctuating at delta p.The vent was returned to the customer and is cleared for clinical use.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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