510(k) K143114
K143114 is an FDA 510(k) premarket notification submitted by Airstrip Technologies, Inc. for the device "Sense4Baby System Model B+ (MSA)". The FDA issued a decision of Substantially Equivalent on March 10, 2015. The device falls under product code LQK (Home Uterine Activity Monitor), a Class II device regulated under 21 CFR 884.2730. Airstrip Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 2015
- Date Received
- October 30, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Home Uterine Activity Monitor
- Device Class
- Class II
- Regulation Number
- 884.2730
- Review Panel
- OB
- Submission Type