510(k) K080375
K080375 is an FDA 510(k) premarket notification submitted by S.L.P. , Ltd. for the device "RMX PHYSIOLOGICAL DATA RECORDER". The FDA issued a decision of Substantially Equivalent on September 2, 2008. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. S.L.P. , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2008
- Date Received
- February 12, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Ventilatory Effort Recorder
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type