510(k) K020312
K020312 is an FDA 510(k) premarket notification submitted by Braebon Medical Corp. for the device "ULTIMA SNORING MIKE, MODEL 0540". The FDA issued a decision of Substantially Equivalent on August 7, 2002. 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
- August 7, 2002
- Date Received
- January 30, 2002
- 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