510(k) K083575
K083575 is an FDA 510(k) premarket notification submitted by Resmed Germany, Inc. for the device "APNEALINK PLUS, MODEL: 22328". The FDA issued a decision of Substantially Equivalent on March 19, 2009. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Resmed Germany, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2009
- Date Received
- December 3, 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