510(k) K151461
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2016
- Date Received
- June 1, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- Device Class
- Class II
- Regulation Number
- 868.5270
- Review Panel
- AN
- Submission Type