510(k) K183559
K183559 is an FDA 510(k) premarket notification submitted by Itamar Medical , Ltd. for the device "WatchPAT ONE". The FDA issued a decision of Substantially Equivalent on Jun 5, 2019. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Itamar Medical , Ltd. has 16 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 5, 2019
- Date Received
- Dec 20, 2018
- 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)