510(k) K140861
K140861 is an FDA 510(k) premarket notification submitted by Somnomedics GmbH for the device "SOMNOTOUCH RESP". The FDA issued a decision of Substantially Equivalent on January 30, 2015. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Somnomedics GmbH has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2015
- Date Received
- April 3, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Effort Recorder
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type