510(k) K080427
K080427 is an FDA 510(k) premarket notification submitted by Itamar Medical for the device "WATCH-PAT MODEL 100S-2". The FDA issued a decision of Substantially Equivalent on May 23, 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
- May 23, 2008
- Date Received
- February 15, 2008
- 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