Breathe Technologies, Inc.

FDA Regulatory Profile

Breathe Technologies, Inc. appears in FDA public data with 0 recalls, 8 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 11, 2017.

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K170037Breathe Technologies Life2000™ Ventilation SystemAugust 11, 2017
K141943BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEMJune 12, 2015
K131562BREATHE NIOV VENTILATION SYSTEMMarch 6, 2014
K130037BREATHE CPAP SYSTEMMay 17, 2013
K103345BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)February 11, 2011
K102525BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)December 2, 2010
K100528BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2SApril 23, 2010
K082982BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIESJuly 20, 2009