510(k) K010889
K010889 is an FDA 510(k) premarket notification submitted by Huntleigh Healthcare, Inc. for the device "BABY DOPPLEX 3000 MK 2 (BD3000)". The FDA issued a decision of Substantially Equivalent on April 25, 2001. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Huntleigh Healthcare, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2001
- Date Received
- March 26, 2001
- Clearance Type
- Special
- 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