510(k) K163696
K163696 is an FDA 510(k) premarket notification submitted by Mycardio, LLC Dba Sleepimage. for the device "SleepImage System". The FDA issued a decision of Substantially Equivalent on Oct 13, 2017. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Mycardio, LLC Dba Sleepimage. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 13, 2017
- Date Received
- Dec 29, 2016
- 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
- 510(k)