510(k) K090499
K090499 is an FDA 510(k) premarket notification submitted by Summit Doppler Systems, Inc. for the device "LIFEDOP MODEL, L350R". The FDA issued a decision of Substantially Equivalent on March 31, 2009. The device falls under product code MAA (Monitor, Fetal Doppler Ultrasound), a Class II device regulated under 21 CFR 884.2660. Summit Doppler Systems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2009
- Date Received
- February 25, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Monitor, Fetal Doppler Ultrasound
- Device Class
- Class II
- Regulation Number
- 884.2660
- Review Panel
- RA
- Submission Type