510(k) K090285
K090285 is an FDA 510(k) premarket notification submitted by Huntleigh Healthcare , Ltd. for the device "SONICAID FM820 AND FM830 ENCORE". The FDA issued a decision of Substantially Equivalent on July 15, 2009. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Huntleigh Healthcare , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 2009
- Date Received
- February 5, 2009
- 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