510(k) K001677
K001677 is an FDA 510(k) premarket notification submitted by Huntleigh Diagnostics , Ltd. for the device "BABY DOPPLEX 4000 (BD4000)". The FDA issued a decision of Substantially Equivalent on August 14, 2000. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Huntleigh Diagnostics , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 2000
- Date Received
- June 1, 2000
- 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