510(k) K112529
K112529 is an FDA 510(k) premarket notification submitted by Advanced Instrumentations, Inc. for the device "TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER". The FDA issued a decision of Substantially Equivalent on October 27, 2011. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660. Advanced Instrumentations, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2011
- Date Received
- August 31, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Ultrasonic, Fetal
- Device Class
- Class II
- Regulation Number
- 884.2660
- Review Panel
- OB
- Submission Type