510(k) K103545
K103545 is an FDA 510(k) premarket notification submitted by Bistos Co., Ltd. for the device "BT-350". The FDA issued a decision of Substantially Equivalent on May 13, 2011. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Bistos Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2011
- Date Received
- December 2, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Monitoring, Perinatal
- Device Class
- Class II
- Regulation Number
- 884.2740
- Review Panel
- OB
- Submission Type