510(k) K143498
K143498 is an FDA 510(k) premarket notification submitted by Life Global Group, LLC for the device "LifeGlobal Global HP". The FDA issued a decision of Substantially Equivalent on January 20, 2015. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Life Global Group, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 2015
- Date Received
- December 10, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type