510(k) K130037
K130037 is an FDA 510(k) premarket notification submitted by Breathe Technologies, Inc. for the device "BREATHE CPAP SYSTEM". The FDA issued a decision of Substantially Equivalent on May 17, 2013. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Breathe Technologies, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2013
- Date Received
- January 7, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Non-Continuous (Respirator)
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type