Breathe Technologies, Inc. · Class II · Cleared Apr 23, 2010
| K-number | K100528 |
| Device name | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S |
| Applicant | Breathe Technologies, Inc. |
| Product code | ONZ |
| Device class | Class II |
| Decision date | Apr 23, 2010 |
| Decision | Substantially Equivalent |
| Regulation | 868.5895 |
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