510(k) K060410
K060410 is an FDA 510(k) premarket notification submitted by Summit Doppler Systems, Inc. for the device "ECHOHEART TRANSVAGINAL DOPPLER PROBE". The FDA issued a decision of Substantially Equivalent on April 10, 2006. The device falls under product code HEK (Monitor, Heart Sound, Fetal, Ultrasonic), 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
- April 10, 2006
- Date Received
- February 16, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Heart Sound, Fetal, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 884.2660
- Review Panel
- OB
- Submission Type