510(k) K081037
K081037 is an FDA 510(k) premarket notification submitted by Itamar Medical for the device "WATCH-PAT 200I (WP200I)". The FDA issued a decision of Substantially Equivalent on June 9, 2008. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Itamar Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 2008
- Date Received
- April 11, 2008
- Clearance Type
- Special
- 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