510(k) K090269
K090269 is an FDA 510(k) premarket notification submitted by Airstrip Technologies, LP for the device "AIRSTRIP OB". The FDA issued a decision of Substantially Equivalent on Feb 13, 2009. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Airstrip Technologies, LP has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 13, 2009
- Date Received
- Feb 3, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Monitoring, Perinatal
- Device Class
- Class II
- Regulation Number
- 884.2740
- Review Panel
- OB
- Submission Type