510(k) K131388
K131388 is an FDA 510(k) premarket notification submitted by Somnetics International, Inc. for the device "TRANSCEND HEATED HUMIDIFIER". The FDA issued a decision of Substantially Equivalent on Sep 26, 2013. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Somnetics International, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 26, 2013
- Date Received
- May 14, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5450
- Review Panel
- AN
- Submission Type
- 510(k)