510(k) K001743
K001743 is an FDA 510(k) premarket notification submitted by Braebon Medical Corp. for the device "ULTIMA SMARTBELT, MODEL 0560". The FDA issued a decision of Substantially Equivalent on August 25, 2000. The device falls under product code BZQ (Monitor, Breathing Frequency), 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 25, 2000
- Date Received
- June 8, 2000
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Breathing Frequency
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type