510(k) K023082
K023082 is an FDA 510(k) premarket notification submitted by Bionet Company, Ltd. for the device "BABYCARE". The FDA issued a decision of Substantially Equivalent on March 3, 2003. The device falls under product code HEP (Monitor, Blood-Flow, Ultrasonic), a Class II device regulated under 21 CFR 884.2660. Bionet Company, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 3, 2003
- Date Received
- September 17, 2002
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Blood-Flow, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 884.2660
- Review Panel
- OB
- Submission Type