510(k) K112317
K112317 is an FDA 510(k) premarket notification submitted by Advanced Instrumentations, Inc. for the device "FM-9000 PLUS FETAL AND MATERNAL MONITOR". The FDA issued a decision of Substantially Equivalent on December 21, 2011. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Advanced Instrumentations, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2011
- Date Received
- August 11, 2011
- 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