510(k) K133859
K133859 is an FDA 510(k) premarket notification submitted by Itamar Medical , Ltd. for the device "WATCH-PAT200U (WP200U)". The FDA issued a decision of Substantially Equivalent on May 30, 2014. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Itamar Medical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 2014
- Date Received
- December 19, 2013
- 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