510(k) K150398
K150398 is an FDA 510(k) premarket notification submitted by Ob Tools, Ltd. for the device "EUM 100Pro". The FDA issued a decision of Substantially Equivalent on August 6, 2015. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 2015
- Date Received
- February 18, 2015
- 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