510(k) K061764
K061764 is an FDA 510(k) premarket notification submitted by Braebon Medical Corp. for the device "MEDIBYTE, MODEL MP8". The FDA issued a decision of Substantially Equivalent on September 6, 2006. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Braebon Medical Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 2006
- Date Received
- June 22, 2006
- 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