510(k) K160499
K160499 is an FDA 510(k) premarket notification submitted by Watermark Medical for the device "Apnea Risk Evaluation System (ARES), Model 620". The FDA issued a decision of Substantially Equivalent on Apr 24, 2017. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Watermark Medical has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 24, 2017
- Date Received
- Feb 23, 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)